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FMT Guidelines

The document presents the second edition of guidelines from the British Society of Gastroenterology and Healthcare Infection Society regarding the use of faecal microbiota transplant (FMT) for treating recurrent or refractory Clostridioides difficile infection (CDI) and other potential indications. Key recommendations include offering FMT after appropriate antibiotic treatment for CDI recurrences and ensuring thorough donor screening to prevent pathogen transmission. The guidelines also address FMT's safety, effectiveness, and considerations for non-CDI applications, emphasizing a structured approach to FMT administration and follow-up.

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FMT Guidelines

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Journal of Hospital Infection xxx (xxxx) xxx

Available online at www.sciencedirect.com

Journal of Hospital Infection

journal homepage: www.elsevier.com/locate/jhin

Guidelines

The use of faecal microbiota transplant as treatment

for recurrent or refractory Clostridioides difficile
infection and other potential indications: second
edition of joint British Society of Gastroenterology
(BSG) and Healthcare Infection Society (HIS) guidelinesq
B.H. Mullish a, b, #, B. Merrick c, #, M.N. Quraishi d, e, f, #, A. Bak g, C.A. Green h, i,
D.J. Moore j, R.J. Porter k, N.T. Elumogo l, m, J.P. Segal n, o, N. Sharma d, e, f,
B. Marsh p, G. Kontkowski p, q, S.E. Manzoor e, A.L. Hart a, r, C. Settle s,
J.J. Keller t, u, P. Hawkey e, v, T.H. Iqbal d, e, f, S.D. Goldenberg c, *, y,
H.R.T. Williams a, b, *, y
a
Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College
London, London, UK
b
Departments of Gastroenterology and Hepatology, St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, UK
c
Centre for Clinical Infection and Diagnostics Research, Guy’s and St Thomas’ NHS Foundation Trust, King’s College London,
London, UK
d
Department of Gastroenterology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
e
Microbiome Treatment Centre, University of Birmingham, Edgbaston, UK
f
Institute of Cancer and Genomic Sciences, University of Birmingham, London, UK
g
Healthcare Infection Society, London, UK
h
Department of Infectious Diseases & Tropical Medicine, University Hospitals NHS Foundation Trust, Birmingham Heartlands
Hospital, Birmingham, UK
i
School of Chemical Engineering, University of Birmingham, Birmingham, UK
j
Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
k
Department of Microbiology, Royal Devon and Exeter Hospitals, Barrack Road, UK
l
Quadram Institute Bioscience, Norwich Research Park, Norwich, UK
m
Norfolk and Norwich University Hospital, Norwich, UK
n
Department of Gastroenterology, Royal Melbourne Hospital, Melbourne, Victoria, Australia
o
Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
p
Lay Representative for FMT Working Party, Healthcare Infection Society, London, UK
q
C.diff support, London, UK

q Published concurrently by both BMJ Publishing Group Limited and the British Society of Gastroenterology in GUT and by Elsevier Ltd on behalf
of the Healthcare Infection Society in the Journal of Hospital Infection. The article is identical in each publication except for minor stylistic and
spelling differences in keeping with each publication’s style. Citations from either of the two publications can be used when citing this article.
* Corresponding authors. Dr Horace R T Williams, Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Imperial
College London, London, UK. Dr Simon D Goldenberg, Centre for Clinical Infection and Diagnostics Research, Guy’s and St Thomas’ NHS Foundation
Trust, King’s College London, London W2 1NY, UK.
E-mail addresses: Simon.Goldenberg@gstt.nhs.uk (S.D. Goldenberg), h.williams@imperial.ac.uk (H.R.T. Williams).
#
BHM, BM and MNQ are joint first authors.
y
SDG and HRTW are joint senior authors.

https://doi.org/10.1016/j.jhin.2024.03.001
0195-6701/ª Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions

S U M M A R Y

Keywords: The first British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS)-
Bacterial infection endorsed faecal microbiota transplant (FMT) guidelines were published in 2018. Over the
Colonic bacteria past 5 years, there has been considerable growth in the evidence base (including
Colonic microflora publication of outcomes from large national FMT registries), necessitating an updated
Diarrhoeal disease critical review of the literature and a second edition of the BSG/HIS FMT guidelines. These
Enteric bacterial microflora have been produced in accordance with National Institute for Health and Care Excellence-
accredited methodology, thus have particular relevance for UK-based clinicians, but are
intended to be of pertinence internationally. This second edition of the guidelines have
been divided into recommendations, good practice points and recommendations against
certain practices. With respect to FMT for Clostridioides difficile infection (CDI), key focus
areas centred around timing of administration, increasing clinical experience of encap-
sulated FMT preparations and optimising donor screening. The latter topic is of particular
relevance given the COVID-19 pandemic, and cases of patient morbidity and mortality
resulting from FMT-related pathogen transmission. The guidelines also considered emer-
gent literature on the use of FMT in non-CDI settings (including both gastrointestinal and
non-gastrointestinal indications), reviewing relevant randomised controlled trials. Rec-
ommendations are provided regarding special areas (including compassionate FMT use),
and considerations regarding the evolving landscape of FMT and microbiome therapeutics.
ª Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions

Executive summary of recommendations

Effectiveness and safety of faecal microbiota transplant (FMT) in treating Clostridioides difficile infection (CDI)
1.1: Offer antibiotics alone in preference to FMT as an initial treatment for CDI (ie, first episode).
1.2: Consider FMT for a first recurrence of CDI or as an adjunct to antibiotics in refractory CDI.
1.3: Offer FMT to all patients with two or more recurrences of CDI.
1.4: Ensure that FMT is preceded by the treatment of CDI with appropriate antibiotics for at least 10 days.
1.5: Offer FMT to all patients, regardless of health status, except those with a known anaphylactic food allergy.
1.6: Offer one or more FMTs after initial clinically assessed FMT failure.
Good practice points (GPPs)
GPP 1.1: Consider FMT earlier than after second CDI recurrence for patients with severe, fulminant or complicated CDI who are not
responding to antibiotic therapy.
GPP 1.2: If FMT was given via endoscopy, ensure that immediate post-endoscopic management after administration is in line with any
local protocols.
GPP 1.3: Inform patients about the short-term adverse events, in particular the possibility of self-limiting gastrointestinal symptoms
and that serious adverse events are rare.
GPP 1.4: Inform patients with inflammatory bowel disease (IBD) with CDI about a small risk of exacerbation of their condition after FMT.
GPP 1.5: Follow-up the FMT recipients for at least 8 weeks to establish its efficacy and adverse events.
GPP 1.6: Do not test for cure by absence of C. difficile after FMT, unless the patient has persistent CDI symptoms or is suspected to have
relapsed.
GPP 1.7: Consider investigation for alternative causes for symptoms in patients who fail to respond to anti-CDI treatment including FMT.
Recipient factors influencing the outcome of FMT for patients with CDI
2.1: Do not refuse or delay FMT therapy due to any recipient risk factors, for example, age over 75 years old, except for patients with
known anaphylactic food allergy.
Donor factors influencing the outcome of FMT for patients with CDI
3.1: Use FMT from universal donors in preference to related donors.

3.2: All potential donors must be screened by questionnaire or personal interview to establish risk factors for transmissible diseases and
for factors that may adversely influence the gut microbiota (box 2).
3.3: Blood and stool of all donors must be tested for transmissible diseases to ensure FMT safety (boxes 3 and 4).
3.4: Discuss and agree the content of Donor Health Questionnaire and laboratory testing at a local level, following a robust risk
assessment.
3.5: Undertake ongoing review, revision and updating of the list of pathogens for screening/testing based on local epidemiology and the
latest evidence.
3.6: Blood and stool of all donors must be rescreened periodically to ensure FMT safety.
3.7: Discuss and agree on the frequency of rescreening depending on local circumstances, but do not allow the bookend periods to be
longer than 4 months.
3.8: Health assessment which captures the donor’s ongoing suitability must be completed at each stool donation.
3.9: Ensure that FMT manufactured from donors is quarantined pending post-baseline screening and test results.
GPPs
GPP 3.1: Follow suggested recommendations in boxes 2e5 for conditions to be included in screening and health questionnaire.
Preparation-related factors influencing the outcome of FMT for patients with CDI
4.1: Frozen FMT must be offered in preference to freshly processed products.
4.2: Process stools aerobically or anaerobicallydboth methods are acceptable.
4.3: Store prepared FMT products frozen at 70 C for up to 12 months.
4.4: Add cryoprotectant such as glycerol to frozen FMT products.
4.5: If capsules are used, these can be obtained from frozen or lyophilised faecal slurry.
GPPs
GPP 4.1: Follow a standard protocol for stool collection.
GPP 4.2: Start processing stools within 150 min of defecation.
GPP 4.3: When possible, use at least 50 g of stool in each FMT preparation.
GPP 4.5: Use sterile 0.9% saline as a diluent for FMT production.
GPP 4.5: Mix a minimum of 1:5 stool with diluent to make the initial faecal emulsion.
GPP 4.6: Consider homogenisation and filtration of FMT in a closed disposable system.
GPP 4.7: Consider thawing frozen FMT at ambient temperature and using it within 6 h of thawing.
GPP 4.8: Avoid thawing FMT in warm water baths, due to the risks of cross-contamination with Pseudomonas spp (and other
contaminants) and reduced bacterial viability.
GPP 4.9: Where glycerol is used as a cryopreservative, ensure it is at 10e15% final concentration of the prepared faecal material/slurry,
with vortexing or other methods used to fully mix the cryopreservative into the material.
Route of delivery and other administration factors influencing the outcome of FMT for patients with CDI
5.1: Choose any route of FMT delivery but, if possible, avoid enema.
5.2: When choosing the route of delivery, consider patient preference and acceptability, cost and the impact on environment.
5.3: Consider enema for patients in whom other FMT delivery methods are not feasible.
5.4: There is no need to administer proton pump inhibitors (PPIs) or other antisecretory agents as a preparation for FMT.
5.5: Do not use antimotility agents as a preparation for FMT.
5.6: Use bowel preparation/lavage as a preparation for FMT.
5.7: After upper gastrointestinal tract administration is used, remove the tube following the flushing with water.
5.8: For patients at risk of regurgitation or those with swallowing disorders, avoid administration via upper gastrointestinal tract and
deliver FMT via lower gastrointestinal tract instead.
5.9: If colonoscopic administration is used, ensure that the FMT is delivered to a site that will permit its retention.
GPPs
GPP 5.1: Use polyethylene glycol preparation as a preferred solution for bowel lavage.
GPP 5.2: Consider using prokinetics (such as metoclopramide) prior to FMT via the upper gastrointestinal tract route.
GPP 5.3: Follow best practice for prevention of further transmission of C. difficile when administering FMT to patients.
GPP 5.4: Consider a washout period of at least 24 h between the last dose of antibiotic and treatment with FMT.
GPP 5.5: If upper gastrointestinal tract administration is used, nasogastric, nasoduodenal or nasojejunal tube, upper gastrointestinal
endoscopy or a permanent feeding tube may be used for delivery.
GPP 5.6: If upper gastrointestinal tract administration is used, administer no more than 100 mL of FMT to the gastrointestinal tract.
Post-FMT factors influencing the outcome of FMT for patients with CDI
6.1: Wherever possible, avoid using non-CDI antibiotics for at least 8 weeks after FMT.
6.2: Consult infection specialists or other appropriate healthcare professionals (eg, gastroenterologists with experience of FMT) for
advice whenever FMT recipients have an indication for long-term antibiotics or have an indication for non-CDI antibiotics within
8 weeks of FMT.
(continued on next page)

Prophylactic FMT treatment to prevent CDI

7.1: No recommendation
FMT for non-CDI indications
8.1: Do not offer FMT routinely to patients with indications other than CDI.
8.2: Consider FMT on a case-by-case basis for patients with ulcerative colitis in whom licensed treatment options have failed or for those
who are not suitable for currently available treatments.
Compassionate use of FMT
9.1: Consider offering compassionate use of FMT in non-CDI settings only when a patient cannot be entered into a clinical trial and after
discussion and approval in a multidisciplinary team (MDT) setting.
9.2: When offering compassionate use of FMT, the following conditions must be met:
e There is a biological rationale to justify consideration.
e Patient is at risk of significant clinical compromise due to a limited alternative range of therapeutic options.
e Patient understands the risks and benefits of FMT compared with other treatment options.
9.3: Prior to treatment, define what will be considered as a success or failure of FMT.
9.4: Prior to treatment, agree potential strategy for further FMTs based on initial clinical success.
Self-banking of stool for potential future autologous FMT
10.1: Do not routinely self-bank stool from faecal material donated by patients or healthy people for potential future autologous FMT.
Regulation and oversight of FMT
11.1: Centres that manufacture and dispense FMT must adhere to any regulations applicable to the area in which they are located.

Patient summary is now entering its second decade of use in modern mainstream
medicine, with the first randomised trial reporting its utility
Faecal microbiota transplant (FMT), sometimes also known following antibiotic treatment in recurrent CDI (rCDI) in 2013
as stool or poo transplantation, can be an effective treatment [2]. The first BSG/HIS-endorsed FMT guidelines were published
for patients with C. difficile (commonly known as C. diff) in 2018 [2], and the interest continues to grow in the use of
infection (CDI). It is usually given when the infection comes FMT, both for CDI and for its potential in the management of
back after antibiotic treatment (relapse), or occasionally if non-CDI conditions [3].
antibiotics do not work (refractory). It is not fully understood Since the first BSG/HIS FMT guidelines in 2018, there has
how FMT helps patients with CDI, but it is thought it is partly to been publication of European and North American CDI-related
do with restoring beneficial gut microorganisms (eg, bacteria) guidelines [4] that have also addressed FMT, consensus reports
and the chemicals (eg, metabolites) they produce. relating to aspects of FMT service design and delivery [5], and
The first British Society of Gastroenterology (BSG)/Health- other BSG guidelines that have made consideration of a role for
care Infection Society (HIS) guidelines on the use of FMT for FMT in a non-CDI setting, for example, for IBD [6]. More
C. diff were published in 2018, and since this time, new evi- recently, the National Institute for Health and Care Excellence
dence has become available. This has prompted this second (NICE) medical technologies guidance summarised the clinical
edition of the guidelines. Key recommendations focus on which and cost effectiveness of FMT, from a UK National Health
patients should be offered FMT, when it should be offered and Service (NHS) perspective [7]. Despite these publications, the
the best ways to administer it. The guidelines also describe BSG and HIS advocated for a second edition of the UK FMT
important considerations for screening of stool donors to guidelines (with the focused version presented here and full
ensure the safety and success of FMT. Two further topics are version available in online Supplemental file A) for a number of
focused on in this second edition. One is the evidence for the reasons. Firstly, the high levels of clinical interest within this
use of FMT for conditions other than CDI, including irritable field mean that this has been a fast-moving area with a rapidly
bowel syndrome (IBS), ulcerative colitis and Crohn’s disease, as growing literature base. Particular areas of evolution since the
well as conditions outside of the gut, such as obesity and last guideline iteration have included randomised trials in both
metabolic syndrome. The second topic considers patients with CDI and non-CDI settings, the reporting of data from regional
conditions in which there are no other treatment options and national FMT registries (with longer periods of follow-up
available to them, and if they can be offered FMT: this is called and larger numbers of patients than were previously descri-
compassionate use. bed), and concerns related to donor screening (relating both to
the COVID-19 pandemic and high profile reports of FMT-related
Introduction pathogen transmission with adverse patient outcomes). Sec-
ondly, while the NICE medical technologies guidance presented
FMT (sometimes referred to by other names, including a general evaluation of the clinical use of FMT, its remit did not
‘intestinal microbiota transplant/transfer [1]) describes the include guidance as to many of the more specific areas related
transfer of minimally manipulated faeces from a healthy to FMT provision and administration that are of greatest rele-
screened donor to a patient for the treatment of disease. FMT vance to practising clinicians in this field (including donor

Aims and scope scanned for additional studies and forward reference searching
(identifying articles which cite relevant articles) was per-
The main purpose of this second edition of the guidelines was formed. The searches were restricted to primary articles
to set recommendations and best practice for the optimal pro- published in the English language.
vision of effective and safe FMT for recurrent or refractory CDI
(defined in box 1) in adult (18 years) patients. The secondary Study eligibility and selection criteria
purpose was to provide guidance for using FMT in conditions Search results were downloaded to Covidence software and
other than CDI in the adult population. These recommendations screened for relevance. Two reviewers discussed their dis-
focused on the provision of FMT in the UK, although many agreements first, and the third reviewer was available to
aspects are also relevant internationally. The focus was on arbitrate but was not needed. The results of study selection
‘minimally manipulated’ stool, and not the ‘next-generation’ and the list of excluded studies for all questions are available in
FMT products (ie, defined microbial communities as ‘micro- online Supplemental appendix 2.
biome therapeutics’). The diagnosis and management of CDI in
general were considered outside the scope of these guidelines. Data extraction and quality assessment
Included epidemiological studies were appraised for quality
Methodology using checklists (links available in online Supplemental
appendix 3A). The results of quality appraisal are available in
Topics for these guidelines were derived from the initial online Supplemental appendix 3B.
discussions of the Working Party during the stakeholder meet- Data were extracted by one reviewer and checked by other
ing. The included questions (online Supplemental appendix 1) reviewers. For each question, the data from the included
were adapted from those in the previous version of the studies were extracted to create the tables of study descrip-
guidelines published in 2018 [1]. Methods were followed in tion and summary of findings tables (online Supplemental
accordance with the NICE manual for conducting evidence appendix 4).
syntheses (online Supplemental file C).
Rating of evidence and recommendations
Data sources and search strategy The strength of the evidence was defined by GRADE (Grading
Three electronic databases (MEDLINE, Embase, Cochrane of Recommendations Assessment, Development and Evalua-
Central Register of Controlled Trials) were searched with the tion) tables (online Supplemental appendix 5) and using the
last search date in July 2023. Search terms were constructed ratings ‘high’, ‘moderate’, ‘low’ and ‘very low’ to construct
using relevant index and free-text terms (online Supplemental the evidence statements, which reflected the Working Party’s
appendix 1). Reference lists of identified relevant articles were confidence in the evidence. The strength of recommendation

Scheduled review General population with CDI

Effectiveness of FMT versus standard care or placebo: there
The guidelines will be reviewed at least every 4 years and was strong evidence which suggested that FMT is more effec-
updated if change(s) are necessary or if evidence emerges that tive than standard care or placebo for preventing CDI recur-
requires a change in practice. rence in the general population [2,12e16].
Adverse events following FMT versus standard care or pla-
Implementation cebo: there was strong evidence which suggested no negative
effect of FMT [2,12e16].
The Working Party agreed that there is no anticipated
additional cost associated with implementation of these Patients with severe, complicated or fulminant CDI
guidelines unless existing practice falls well below currently Effectiveness of FMT in patients with severe CDI: there was
accepted standards. Assessing the cost-effectiveness of dif- weak evidence which suggested that FMT is beneficial in this
ferent treatments is not within the scope of this guidance. The patient group [17].
practices recommended by these guidelines are currently used Effectiveness of FMT in patients with severe CDI compared
in most centres offering FMT in the UK. There is a potential with patients with mild/moderate CDI: there was moderate
cost-saving and other benefits (eg, reducing the carbon foot- evidence which suggested there was no difference between
print) when certain recommendations are followed (eg, donor these two patient groups [18e24].

Patients with cancer with CDI Patients with COVID-19 infection and CDI
Effectiveness of FMT: there was weak evidence which sug- Effectiveness of FMT: there was weak evidence which sug-
gested that FMT is effective in this patient group [45,46]. gested that FMT is effective in this patient group [50].
Effectiveness in patients with cancer compared with Effectiveness in patients with COVID-19 compared with
patients with no cancer: there was weak evidence, but it patients without COVID-19: there were no studies.
suggested that there was no difference in the effectiveness Adverse events: there was weak evidence which suggested
between these two patient groups [19,21,40]. FMT is safe in this patient group [50].
Adverse events: there was weak evidence which suggested
that FMT was safe in this patient group [45,46]. Patients with CDI and other conditions
Effectiveness of FMT: there were no studies.
Post-solid organ transplant patients with CDI Effectiveness in patients with other conditions compared
Effectiveness of FMT: there was weak evidence which sug- with patients without these conditions: there was weak evi-
gested that FMT is effective in this patient group [47]. dence, which suggested that there is no difference in the

Please cite this article as: Mullish BH et al., The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides
difficile infection and other potential indications: second edition of joint British Society of Gastroenterology (BSG) and Healthcare Infection
Society (HIS) guidelines, Journal of Hospital Infection, https://doi.org/10.1016/j.jhin.2024.03.001
8 B.H. Mullish et al. / Journal of Hospital Infection xxx (xxxx) xxx
effectiveness of FMT between these patient groups The Working Party discussed the above evidence and con-
[19,22,38,39]. cluded that FMT administered after CDI treatment with
Adverse events: there were no studies. appropriate antibiotics appears to be more effective than
placebo, or additional doses of vancomycin or fidaxomicin, in
Patients with CDI and multiple comorbidities prevention of CDI recurrence. However, the sensitivity analyses
Effectiveness of FMT: there were no studies. performed due to high heterogeneity suggest that its effec-
Effectiveness in patients with multiple comorbidities tiveness depends on many factors, including the route of FMT
compared with patients without comorbidities: there administration, the number of FMTs given, the type of patient,
was weak evidence which suggested that FMT may be less and the length of follow-up. It is also important to highlight
successful in patients with multiple comorbidities that the high heterogeneity was also a result of different types
[20,27,37,44,51,52]. of comparisons, which are typically used in clinical practice
Adverse events: there were no studies. and constitute standard care; for example, in some studies,
participants were given initial antibiotics to treat CDI and
Additional data from excluded studies received placebo as a part of standard care while in other
Quality of life. One study [53] reported improved quality of studies, participants received the initial antibiotics for treat-
life after the patients underwent FMT for CDI. ment as well as additional doses of vancomycin or fidaxomicin
as a comparison with FMT. In either case, FMT was more
Mortality. Two studies [54,55] reported no difference in mor- effective than any of these standard regimens. The results of
tality rates, one [56] reported that the incidence of CDI-related one randomised controlled trial (RCT) [5] support previous
mortality decreased when an FMT programme was introduced, observational reports that retention enema is not an efficient
one [23] reported that early FMT reduced mortality in severe route of administration.
cases, and one study [57] reported that patients who received Additionally, FMT seems to be beneficial for patients with
FMT had a 77% decrease in odds of mortality. different types of comorbidity regardless of the severity or
phenotype of CDI and the number of CDI episodes preceding
Long-term effectiveness. Six studies [23,58e62] reported that FMT. The Working Party acknowledged that some types of
at long-term follow-up (up to 1 year), FMT was still effective. comorbidities and multiple comorbidities may make the FMT
less effective, and that for these patients, more than one FMT
Asymptomatic carriage after FMT. One study [63] reported may be required. Clinically, this would be similar for all
that asymptomatic carriage of C. difficile after FMT is rare. patients because subsequent FMT, preferably from a different
donor, should be offered if the first FMT fails. One dose of FMT
New or worsening symptoms following FMT. One study [23] may be less effective in patients with severe or pseudomem-
reported that 1 year after follow-up, nausea was present in 18% branous colitis and to achieve a desired effect, these patients
of the patients, abdominal pain in 21% and diarrhoea in 33%, could benefit from additional doses. However, clinically, this
but that no serious events related to FMT occurred. One study issue may not be relevant because in practice, patients with
[59] reported that within a year after FMT, the prevalence of CDI are not routinely assessed for the presence of pseudo-
constipation increased, but that most of the cases did not need membranous colitis. Therefore, the clinical pathway for these
treatment. Other symptoms included urgency, cramping and an patients would remain similar to patients with other CDI types.
increased incidence of IBS. Two years after FMT, new con- Nevertheless, FMT in these patients still appears to be better
ditions included weight gain, diabetes mellitus, dyslipidaemia, than placebo or antibiotics alone. Thus, FMT should be given for
thyroid problems, gastrointestinal problems and serious different types of patients, regardless of their comorbidities or
infections. These conditions were not considered directly the type of CDI. As per the previous iteration of the guidelines,
linked to FMT. Other studies reported the onset of the following the Working Party discussed that the only absolute contra-
new issues [36,54,60,62], but none of these conditions were indication for FMT is the presence of anaphylactic food allergy.
assessed for causality. One study reported worsening pre- In previous guidelines, there was a concern that FMT may
existing chronic IBD and rheumatoid arthritis [60]. One study cause harm in some types of patients, including those who are
[64] reported that there was a slightly higher incidence of immunocompromised or immunosuppressed, those with liver or
myocardial infarction in FMT group compared with non-FMT at kidney disease or those with IBD. However, the evidence now
1 year follow-up, but that the incidence of other conditions was suggests that the incidence of adverse events, regardless of
similar. At 10-year follow-up, one study [65] reported that their severity, appears to be similar in different types of
there were no new diagnoses of autoimmune diseases, gas- patients. Thus, the Working Party agreed that FMT should still
trointestinal disorders or malignancies and that there were no be considered as a treatment option for patients with comor-
deaths which were attributed to FMT. bidities based on its safety. Moreover, in the general pop-
ulation, the incidence of adverse events in patients who
Resolution or improvement of conditions following receive FMT does not appear to be different when compared
FMT. Three studies reported resolution or improvement of with patients who receive placebo or anti-CDI antibiotics. The
existing conditions following FMT [54,60,62], including erad- Working Party would also like to stress that, due to the similar
ication of multidrug-resistant microorganisms [54], improve- incidence of occurrence in different treatment groups, gas-
ment of undifferentiated colitis, Crohn’s disease, ulcerative trointestinal events such as diarrhoea, nausea or bloating are
colitis, diabetes mellitus and Parkinson’s disease [62], and probably more likely to be associated with CDI itself and pos-
improvement of IBS, IBD and alopecia areata [60]. None of sibly some co-interventions (eg, bowel preparation) rather
these studies investigated whether these improvements were than with FMT treatment. Based on clinical experience of the
directly associated with FMT. Working Party members, adverse events, none of which were

Recommendations
1.1: Offer antibiotics alone in preference to FMT as an initial treatment for CDI (ie, first episode).
1.2: Consider FMT for a first recurrence of CDI or as an adjunct to antibiotics in refractory CDI.
1.3: Offer FMT to all patients with two or more recurrences of CDI.
1.4: Ensure that FMT is preceded by the treatment of CDI with appropriate antibiotics for at least 10 days.
1.5: Offer FMT to all patients, regardless of health status, except those with a known anaphylactic food allergy.
1.6: Offer one or more FMTs after initial clinically assessed FMT failure.
GPPs
GPP 1.1: Consider FMT earlier than after second CDI recurrence for patients with severe, fulminant or complicated CDI who are not
responding to antibiotic therapy.
GPP 1.2: If FMT was given via endoscopy, ensure that immediate post-endoscopic management after administration is in line with any
local protocols.
GPP 1.3: Inform patients about the short-term adverse events, in particular the possibility of self-limiting gastrointestinal symptoms
and that serious adverse events are rare.
GPP 1.4: Inform patients with IBD with CDI about a small risk of exacerbation of their condition after FMT.
GPP 1.5: Follow-up the FMT recipients for at least 8 weeks to establish its efficacy and adverse events.
GPP 1.6: Do not test for cure by absence of C. difficile after FMT, unless the patient has persistent CDI symptoms or is suspected to have
relapsed.
GPP 1.7: Consider investigation for alternative causes for symptoms in patients who fail to respond to anti-CDI treatment including FMT.

pressed/immunocompromised patients (8%). For specific Recipient factors influencing the outcome of FMT for
adverse events, the incidence was 0.19% (95% CI 0.09%e0.31%) patients with CDI
for sepsis or sepsis-like conditions, 0.27% (95% CI 0.15%e0.43%)
for aspiration pneumonia and 0.20% (95% CI 0.09%e0.34%) for The evidence above demonstrates that FMT is generally
bowel perforation. Mild adverse events were also relatively effective in the majority of individuals regardless of their
rare, with constipation reported in 1.03% (95% CI 0.77%e1.33%) health status. Despite this, there are still patients in whom
of the patients, abdominal pain in 1.66% (95% CI 1.33%e2.03%), FMT fails. Risk factors for CDI recurrence after FMT are poorly
nausea in 0.92% (95% CI 0.67%e1.20%), vomiting in 0.34% (95% understood, but certain patient characteristics such as
CI 0.20%e0.52%), flatulence in 0.70% (95% CI 0.49%e0.94%) and advanced age, female sex and some medications have been
febrile episodes in 0.33% (95% CI 0.19%e0.50%) of patients proposed as potential predictors for failure [67]. There may
following FMT. In general, the majority of adverse events seem also be some additional modifiable factors which could be
to occur either due to unsafe FMT products or unsafe practice optimised before FMT is given and these have not yet been
of administration, both of which are avoidable when careful explored. Despite some studies reporting some patient char-
donor screening is in place and appropriate care is given to FMT acteristics as risk factors, the results have been mostly
recipients. Other events may be unpreventable, for example, inconsistent. Additionally, there remain concerns about the
diarrhoea due to glycerol being used as cryoprotectant, but safety of FMT for some patients. Underlying vulnerabilities
these are relatively minor and self-limiting. such as older age and the effect of some medications could
The data from the excluded studies point out that the potentially increase an individual’s risk of severe adverse
desired effects of FMT are generally long-lasting with many events associated with FMT. Previous BSG/HIS guidelines [3]
patients experiencing no recurrence of CDI and no evidence of did not identify any risk factors for CDI recurrence other than
adverse events occurring months to years after FMT. There are post-FMT antibiotics. The guidelines also found very little
some patients who experience recurrence or relapse and the evidence that would demonstrate the safety of FMT in more
Working Party discussed how these patients should be man- vulnerable populations. As a result, the guidelines recom-
aged. It was concluded that current evidence [23] and clinical mended caution when administering FMT to people with cer-
practice support the treatment of these patients with either tain conditions such as immunosuppression or liver disease
further FMT or anti-CDI antibiotic therapy. and suggested that antibiotic therapy should be avoided or
The Working Party discussed whether, due to an apparent delayed when possible.
benefit, FMT should be offered as a treatment for patients
with the first episode of CDI. The effectiveness for patients Demographic factors
experiencing the first or second CDI has recently been Age. Effect on success rates: there was moderate evidence
established in one RCT [13]. However, due to the fact that which suggested that this does not influence the effectiveness
FMT may be more invasive and expensive compared to of FMT [19e23,26e28,37e40,44,68,69].

Hospitalisation due to CDI. Effect on success rates: there was Blood biomarkers. Effect on success rates: there was weak
weak evidence which suggested that this does not influence the evidence which suggested that these do not influence the
effectiveness of FMT [19,38]. effectiveness of FMT [20,28,51] However, one study [51]
Effect on adverse events: there were no studies. reported a higher risk of recurrence of CDI in patients with zinc
deficiency as well as a beneficial effect for zinc-deficient
Antibiotics used for treatment of CDI before FMT. Effect on patients who were given zinc supplements.
success rates: there was weak evidence which suggested that Effect on adverse events: there were no studies.
these do not influence the effectiveness of FMT
[19,22,39,40,69]. Other risk factors. Effect on success rates: there was weak
Effect on adverse events: there were no studies. evidence which suggested that these do not influence the
effectiveness of FMT [27,38,41,69].
C. difficile strain. Effect on success rates: there was weak Effect on adverse events: there were no studies.
evidence which suggested that this does not influence the Upon reviewing the above evidence, the Working Party
effectiveness of FMT [21,23,41]. agreed that there are currently no identified factors which
Effect on adverse events: there were no studies. affect the effectiveness of FMT. There may be some charac-
teristics of CDI infection that may result in FMT being less
Healthcare-acquired CDI. Effect on success rates: there was effective; however, as was highlighted in a previous section,
weak evidence which suggested that this does not influence the FMT is still more effective than standard antibiotics and pla-
effectiveness of FMT [20]. cebo. Adverse events were assessed only for patients’ age and
Effect on adverse events: there were no studies. the evidence suggested that age had no effect. The Working
Party agreed that the paucity of studies reporting adverse
Other risk factors events for patients with different characteristics likely repre-
Use of PPIs and other antisecretory medications. Effect on sents the lack of effect of these characteristics on the inci-
success rates: there was moderate evidence which suggested dence and severity of adverse events. Based on these
that these do not influence the effectiveness of FMT conclusions, the Working Party agreed that FMT should not be
[19,20,22,23,26,28,37,38,40,41]. declined or delayed based on any patient-related or CDI-
Effect on adverse events: there were no studies. related characteristic.
Additionally, the Working Party agreed that further studies
Use of corticosteroids preceding the administration of investigating the effect of simple non-modifiable risk factors
FMT. Effect on success rates: there was weak evidence which (eg, age, sex, etc) are not necessary because the existing
suggested that these do not influence the effectiveness of FMT studies suggest that these factors are not likely to influence the
[40]. effectiveness or adverse events of FMT to the point where
Effect on adverse events: there were no studies. antibiotics and/or other therapies should be considered as an
alternative. As such, future studies should focus on inves-
Use of lactulose preceding the administration of FMT. Effect tigating modifiable risk factors which can be corrected before
on success rates: there was weak evidence which suggested FMT is given so that its outcomes are optimised. A recent
that this does not influence the effectiveness of FMT [40]. review [70] identified possible recipient factors which facili-
Effect on adverse events: there were no studies. tated donor microbiota engraftment, including genetics,

Recommendation
2.1: Do not refuse or delay FMT therapy due to any recipient risk factors, for example, age over 75 years old, except for patients with
known anaphylactic food allergy.
GPP
GPP 2.1: None

Donor factors influencing the outcome of FMT for spective donors should be tested for other, non-
patients with CDI gastrointestinal pathogens, to ensure the safety of recipients.

A robust donor screening programme is an essential part of Related versus not related donor
FMT services to ensure safety for FMT recipients. Donor Effect on success rates: there was weak evidence which
recruitment is challenging; using standard criteria applied in suggested that this does not influence the effectiveness of FMT
many FMT services to ensure safety and efficacy, one recent [22,24,52].
study reported that only 1.7% of prospective candidates Effect on adverse events: there were no studies.
qualified as suitable donors [71]. Moreover, the study reported
that due to a lengthy screening process, as many as 39% of the Age of the donor
candidates were lost to follow-up even before their suitability Effect on success rates: there was weak evidence which
was established. The reluctance of the public to donate their suggested that this does not influence the effectiveness of FMT
stool is also well documented and seems to stem from the [23,27].
social perception of stool, the lack of awareness of the Effect on adverse events: there were no studies.
importance of donation, and the logistic difficulties in collec-
tion and transport of the stool [72]. Evidently, there is a need Sex of the donor
for a pragmatic approach for the recruitment and screening of Effect on success rates: there was weak evidence which
potential donors. suggested that this does not influence the effectiveness of FMT
The primary aim of donor screening is mitigating risk of [23].
pathogen transmission via FMT. A secondary aim of donor Effect on adverse events: there were no studies.
screening is to exclude potential donors who may have an
‘aberrant/adverse’ gut microbiome. While the complexity and Amount of stool produced
relative novelty of exploration of the gut microbiome mean Effect on success rates: there was weak evidence which
that there is no clear agreed definition of what a ‘healthy’ or suggested that this does not influence the effectiveness of FMT
‘unhealthy’ gut microbiome is [73], either compositionally or [27].
functionally, there is the theoretical potential for transmission Effect on adverse events: there were no studies.
of gut microbiome traits (and therefore potential for trans-
mission of risk of diseases with a link to the gut microbiome) via Microbiome composition of the donor
FMT. There are also some studies that include microbiome Effect on success rates: there was weak evidence which
sequencing and other approaches to try and find which bacteria suggested that this does not influence the effectiveness of FMT
transplanted from donor to recipient are associated with suc- [27].
cess [74,75]. So far, it has been difficult to define a core set of Effect on adverse events: there were no studies.
bacteria or functions underlying a good donor or successful The Working Party reviewed the above evidence and con-
FMT. At the moment, there is little evidence which allows FMT cluded that it is likely that routinely measured donor factors do
services to define a healthy microbiome which is most optimal not influence the effectiveness of FMT for treatment of CDI.
for donation. Previous BSG/HIS guidelines [3] acknowledged The Working Party agreed that the use of universal donors is the
that research into donor factors is lacking. Therefore, the most practical and cost-effective way to obtain donor stools.
guidelines recommended a general approach that all healthy The previous practice of using related donors, which in early
adults under 60 years of age with body mass index (BMI) under days before stool banks existed were the most reliable source
30 kg/m2 could be potential candidates for donor screening. of donor stools, is now outdated and should be avoided. There
The recommendations then focused on an initial screening is no established evidence that stools from a related donor
using a health and travel questionnaire, followed up by a bat- influence the effectiveness of the FMT, but there may be
tery of laboratory testing of blood and stools to further ensure logistical difficulties and potentially additional costs related to
the safety of FMT material. The guidelines also recommended donor screening. There is also a concern that stool microbiota
regular reassessment of donors to ensure continuing safety. may be less diverse in these donors. As a related donor may
Since the guidelines were published, more evidence has cohabit with a recipient, the overlap of environmental factors

Please cite this article as: Mullish BH et al., The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides
difficile infection and other potential indications: second edition of joint British Society of Gastroenterology (BSG) and Healthcare Infection
Society (HIS) guidelines, Journal of Hospital Infection, https://doi.org/10.1016/j.jhin.2024.03.001
12 B.H. Mullish et al. / Journal of Hospital Infection xxx (xxxx) xxx
with the patient (eg, diet) may affect their gut microbiome and Regarding the recommended Donor History Questionnaire,
the success of FMT. the Working Party provided some updates to this compared
There were no studies which investigated whether the with the original version of this guideline (box 2). For instance,
donor factors affected the incidence or severity of adverse the assessment for risk factors for bloodborne viruses has been
events, but the members agreed that, apart from the compo- updated to be consistent with those from UK Blood and
sition of the microbiota, they are not likely to influence the Transplant. The Working Party noted that FMT services in cer-
effectiveness of FMT. As mentioned above, some studies tain settings aimed to recruit donors from within blood
demonstrate that the composition of microbiota of the donor
stool may predict the success or failure of FMT [74,75], but
none of these studies met the inclusion criteria for these
Box 2
guidelines. The Working Party stressed that wherever donor
Recommended Donor History Questionnaire
factors have been investigated, this was done in situations in
which all donors were screened for possible transmissible dis-
Positive response to any of these questions may exclude fur-
eases and where safety of FMT material was established.
ther consideration regarding donation at that time; it may be
Therefore, they stated that screening of all donors must remain appropriate to rescreen and consider for donation at a later
in place to ensure the safety of FMT recipients. All donors time point based on the particular scenario.
should also be rescreened regularly to ensure ongoing safety.
e Receipt of antibiotics and/or other medications potentially
Rationale for recommendations on overall approach to associated with gut microbiome perturbation, to include
donor screening (but not limited to) proton pump inhibitor, statin, immu-
The Working Party agreed a robust donor screening proce- nosuppression, and/or chemotherapy, within the past
3 months.
dure remains mandatory. As per the original version of these e Known prior exposure to HIV and/or viral hepatitis, within
guidelines, the screening should continue to comprise a ques- the past 3 months.
tionnaire, to identify risk factors for an aberrant microbiome e Known previous or latent tuberculosis.
and pathogen carriage, and laboratory-based testing for e Use of illicit drugs, any tattoo, body piercing, needlestick
pathogen detection. This should be an ongoing process that is injury, blood transfusion, acupuncture (outside of
repeated at appropriate intervals. licensed or approved UK facilities), all within the previous
4 months.
The Working Party discussed the reported FMT complica-
e New or multiple (more than one) sexual partners within
tions since the last guidelines which might influence updates the past 3 months.
in the recommended donor screening protocols. From one e Sex with somebody diagnosed with HTLV-1 and HTLV-2*.
perspective, there have been a number of reported cases of e Previously living in areas with high prevalence of HTLV-1
infection post-FMT apparently related to pathogen trans- and HTLV-2*.
mission which may have been mitigated by additional donor e Receipt of a live-attenuated vaccine within the past
6 months.
screening processes, including C. perfringens [76], atypical
e Cold sores, anal ulcers, anal sores, pruritus ani within the
enteropathogenic Escherichia coli [77] and Shiga toxin- past 3 months.
producing E. coli [78]. It is also important to highlight the e Underlying gastrointestinal conditions/symptoms (eg,
well-publicised case of FMT-related infection transmission in history of IBD, IBS, chronic diarrhoea, chronic con-
two immunosuppressed patients who developed bloodstream stipation, coeliac disease, bowel resection or bariatric
infection after transmission of E. coli carrying an extended- surgery).
spectrum beta-lactamase via FMT, leading to one death. e Acute diarrhoea/gastrointestinal symptoms within the
past 2 weeks.
[79,80] There had been considerable concern since the e Family history of any significant gastrointestinal con-
emergence of SARS-CoV-2 regarding its potential for trans- ditions (eg, family history of IBD or colorectal cancer).
mission via FMT (particularly related to its potential route of e History of atopy (eg, asthma, eosinophilic disorders).
entry via the luminal tract and well-described gastro- e Any systemic autoimmune conditions.
intestinal symptoms related to infection), and rapid con- e Any metabolic conditions, including diabetes and obesity.
sensus updates to donor screening were introduced to e Any neurological or psychiatric conditions.
e History of chronic pain syndromes, including chronic
mitigate risk. [81] However, despite this theoretical risk,
fatigue syndrome and fibromyalgia.
there are no reported cases of FMT-related SARS-CoV-2 e History of any malignancy.
transmission described, to the knowledge of the Working e History of receiving growth hormone, insulin from cows
Party. Since the last guideline, there has been an increased or clotting factor concentrates, or known risk of prion
period of time for reporting of registry data and of pro- disease.
spective case series. Overall, FMT for rCDI appears safe with e History of receiving an experimental medicine (including
vaccines) within the past 6 months.
several years of follow-up post-treatment; there have been
e History of travel to tropical countries within the past
very few cases of infection potentially attributable to FMT 6 months.
and very low rates of new diseases which might feasibly be
attributable to FMT [23,36,54,58e62,64e66]. There is a need
*This question to be asked in centres where laboratory
to strike an appropriate balance between screening practices
screening for HTLV-1 and HTLV-2 may be difficult; areas to
that are robust enough to mitigate the potential risks of focus on, but not limited to: Japan, the Caribbean, and South
providing FMT while allowing sufficient pragmatism. Overly America.
stringent screening focused on theoretical risk of every
HTLV, human T-cell lymphotropic virus; IBD, inflammatory
possible pathogen risks making the process impossible to bowel disease; IBS, irritable bowel syndrome.
comply with.

e Clostridioides difficile tcdB (toxin B) by PCR*

Box 3 e Campylobacter, Salmonella and Shigella, preferably by
Recommended blood screening for donors PCR
e Shiga toxin-producing Escherichia coli by PCR
Pathogen screening: e Other enteropathogenic E. coli, including, but not limited
to, enteropathogenic E. coli by PCR
e Hepatitis A IgM e Multidrug-resistant bacteria, including, but not limited to,
e Hepatitis B (HBsAg and HBcAb) carbapenemase-producing Enterobacterales, extended-
e Hepatitis C antibody spectrum beta-lactamases and vancomycin-resistant
e Hepatitis E IgM enterococci**
e HIV-1 and HIV-2 antibodies e Stool ova, cysts and parasite analysis, including:
e HTLV-1 and HTLV-2 antibodies B Cryptosporidium and Giardia antigen or PCR
e Treponema pallidum antibodies (TPHA, VDRL) B Acid fast staining for Cyclospora, Isospora and
e Epstein-Barr virus (EBV) IgM and IgG* Microsporidia
e Cytomegalovirus (CMV) IgM and IgG* e Norovirus and rotavirus PCR
e Strongyloides stercoralis IgG e SARS-CoV-2***
e Entamoeba histolytica serology e Helicobacter pylori stool antigen****
e Cysticercal serology
* Glutamate dehydrogenase (GDH) screening for possible C.
General/metabolic screening: difficile is not required or recommended; where performed, a
positive GDH would not be sufficient to exclude a donor on the
e Full blood count with differential grounds of ‘positive C. difficile status’.
e Creatinine and electrolytes **Methicillin-resistant Staphylococcus aureus is primarily
e Liver enzymes and liver function tests recognised as a skin rather than a gastrointestinal organism;
e C reactive protein therefore, screening is not universally recommended.
***Based on current prevalence and laboratory expertise, a
*EBV and CMV testing is recommended where there is the broader viral screen may be appropriate, ideally via multiplex
potential that the FMT prepared from that donor will be panel, which may include, for example, sapovirus and
administered to immunosuppressed patients at risk of severe poliovirus.
infection if exposed to CMV and EBV.
****Consider testing but not necessarily to exclude as a donor
FMT, faecal microbiota transplant; HBcAb, hepatitis B core if positive; may potentially wish to consider informing any
antibody; HBsAg, hepatitis B surface antigen; HTLV, human T- recipients of H. pylori stool antigen-positive material, espe-
cell lymphotropic virus; TPHA, T. pallidum haemagglutination cially if recipients do not have a background of/are not cur-
assay; VDRL, Venereal Disease Research Laboratory. rently H. pylori stool antigen positive.

Please cite this article as: Mullish BH et al., The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides
difficile infection and other potential indications: second edition of joint British Society of Gastroenterology (BSG) and Healthcare Infection
Society (HIS) guidelines, Journal of Hospital Infection, https://doi.org/10.1016/j.jhin.2024.03.001
14 B.H. Mullish et al. / Journal of Hospital Infection xxx (xxxx) xxx
could be made for continuing with this approach based on risk such bacteria or their genes as part of donor screening. Addi-
assessment at present, the currently evolving risk landscape tionally, since the durability of engraftment of donor strains
related to SARS-CoV-2 (related to a number of factors, after a single FMT is variable but may be only several months in
including national COVID-19 vaccination roll-out) may mean the case of a reasonable proportion of taxa [73], the real
that a modified protocol for SARS-CoV-2 screening may become procarcinogenic risk could be even lower than previously sug-
appropriate over the lifetime of this guideline. Similarly, the gested, should bacteria with these gene cassettes be those
Working Party noted a report of atypical enteropathogenic E. with limited colonisation duration. Further studies within this
coli transmission related to FMT, and as such felt that more field should be undertaken and results monitored. The Working
considered screening for this in donors was justified [77]. The Party noted that FMT for rCDI is often being used in an older and
Working Party also discussed that new evidence had emerged frail population for whom the risk-to-benefit ratio of FMT is
since the last version of the guidelines that suggested against being considered over a fairly short period, that is, patients
certain gastrointestinal pathobionts being transmitted via FMT. with limited alternate therapeutic options, with the aim of
In particular, a Danish FMT service recently described 13 out of minimising further hospital admissions. This ratio would be
40 donors as being Helicobacter pylori stool antigen positive, different in the context of younger patients, particularly where
but that 26 FMTs administered from five positive donors had not FMT was used on a more exploratory basis, and this may influ-
resulted in any recipients becoming H. pylori stool antigen ence the importance of considering the potential future role
positive at a median of 59 days [83]. While these data do not for screening for such bacteria.
support the need for H. pylori stool antigen being part of The Working Party also noted that a number of studies had
screening, the Working Party also discussed the different risk proposed using stool metagenomics as a tool to assess stool
burden that theoretical H. pylori transmission might have in the donors, and proposed a variety of ecological or taxonomy-
UK versus in the Far East, given its association with gastric based metrics to select out and stratify potentially ‘ideal’
cancer. It was noted that there are recent data demonstrating donors [88]. Discussions within the Working Party concluded
transmission of Blastocystis via FMT, but that this did not that while this was of research interest, there was no justifi-
influence success of FMT as treatment for rCDI, and it was not cation for use of any assessment of this nature as part of the
associated with any gastrointestinal symptomatology over donor screening/selection process at present. It was also
months of follow-up, suggesting no need to intensify donor observed that a small number of studies had suggested a
screening for this organism [84]. potential role for additional modalities of laboratory assess-
The Working Party noted recent literature exploring the ment as part of donor screening; for instance, one study
impact of FMT upon the gut microbiota dynamics of potentially observed a trend towards increased gastrointestinal symptoms
procarcinogenic bacteria. This topic first came to light from a post-FMT for rCDI after receipt of FMT from a donor with pos-
study of 11 paediatric patients with rCDI (of whom 6 had itive small intestinal bacterial overgrowth, as assessed by
underlying IBD), in whom 4 patients were found to have sus- positive lactulose breath test [89]. Again, the Working Party
tained acquisition of procarcinogenic bacteria post-FMT, after felt that while this was of interest and supported future
transmission from colonised donors. It was also noted that two research, there was no current justification for this to be
patients experienced clearance of such bacteria after FMT incorporated into the donor screening process.
from a negative donor [85]. Using full genome sequencing, one As per their discussions regarding the health questionnaire,
of these patients acquiring procarcinogenic bacteria was shown the Working Party felt that it was beyond the scope to mandate
to have durable donor-to-recipient transmission of E. coli with or exclude specific laboratory tests. Thus, the lists given in
the colibactin gene (clbB), which has been associated with boxes 3 and 4 reflect suggested best practice but not compul-
colonic tumours [86]. A further retrospective study [87] ana- sory testing. Laboratory-based testing and clinical inter-
lysed stool metagenomes of matched pre-FMT versus post-FMT pretation of results should be performed and agreed at a local
samples from 49 patients with rCDI, together with their level following a robust risk assessment. Consistent with this,
matched donors. This showed higher prevalence and abun- the Working Party noted the differences in laboratory donor
dance of potentially procarcinogenic polyketide synthase- screening approaches that are reported in different regions
positive (pksþ) E. coli in the gut microbiome of patients with globally. These are consistent with the different prevalence
rCDI compared with their healthy donors, and that the pks and risk profile of different pathogens within each region [90].
status of the post-FMT gut microbiome related to the pks status As highlighted by the case of COVID-19, the list of pathogens for
of the donor being used (with pks being negative in five out of which testing is undertaken needs to be constantly reviewed,
eight of their donors at all time points sampled and detected in revised and updated, based on local epidemiology and the
overall low levels otherwise). More specifically, persistence (8 latest evidence base. One area that may require particular
out of 9 patients) or clearance (13 out of 18 patients) of pksþ E. focus in this regard is the potential for emergence of new viral
coli in pksþ patients correlated with pks in the donor pathogens or rise in population prevalence of known viral
(P¼0.004). While these data are of interest, the Working Party pathogens with established faecal-oral transmission, for
concluded that the small number of publications on this topic, example, poliovirus; the pertinence of this is highlighted by its
unclear understanding of the true potential causative pro- detection within sewage water in London in 2022 [91,92].
carcinogenic nature of the bacteria being studied, and overall The Working Party no longer supports the use of fresh FMT,
reassuring safety profile of FMT meant that there was no cur- because this approach does not allow for direct testing of the
rent clinical indication for routine metagenome screening for donor stool used to manufacture FMT prior to administration

Recommendations
3.1: Use FMT from universal donors in preference to related donors.
3.2: All potential donors must be screened by questionnaire or personal interview to establish risk factors for transmissible diseases and
for factors that may adversely influence the gut microbiota (box 2).
3.3: Blood and stool of all donors must be tested for transmissible diseases to ensure FMT safety (boxes 3 and 4).
3.4: Discuss and agree the content of the Donor Health Questionnaire and laboratory testing at a local level, following a robust risk
assessment.
3.5: Undertake ongoing review, revision and updating of the list of pathogens for screening/testing based on local epidemiology and the
latest evidence.
3.6: Blood and stool of all donors must be rescreened periodically to ensure FMT safety.
3.7: Discuss and agree on the frequency of rescreening depending on local circumstances, but do not allow the bookend periods to be
longer than 4 months.
3.8: Health assessment which captures the donor’s ongoing suitability must be completed at each stool donation.
3.9: Ensure that FMT manufactured from donors is quarantined pending post-baseline screening and test results.
GPP
GPP 3.1: Follow suggested recommendations in boxes 2e5 for conditions to be included in screening and health questionnaire.

and does not allow for a period of quarantine in the case where Preparation-related factors influencing the outcome
additional donor testing may be required. Stool may be pro- of FMT for patients with CDI
cessed into FMT immediately from donors who have passed
baseline screening, but the Working Party agreed that it should The effectiveness of FMT is presumed to depend on trans-
initially be quarantined. The Working Party also agreed that ferred commensal microbiota being able to engraft and pro-
post-baseline screening is required prior to release of FMT from liferate in the recipient’s colon. Thus, preservation of viability
quarantine to further mitigate the risk of pathogen trans- of relevant bacteria during processing and storage is consid-
mission. This post-baseline donor screening needs to take a ered an important factor for FMT effectiveness. At the
safe but pragmatic approach, and should cover two aspects: moment, there is no standard approach to how donated stools
are processed and stored, although it has been suggested that
e Bookend testing (box 5) on donated stool to pick up variations in processing seem to have little influence on FMT
acquisition of asymptomatic, transmissible enteric patho- effectiveness for rCDI [93]. Due to the difficulties with donor
gens during the donation period. Again, the exact frame- recruitment, as well as an additional benefit of quarantine of
work should be defined by local policies and donation the donor stools, the desire is to keep FMT product for as long
schedules, following a robust risk assessment. However, as possible. Longer storage is also helpful if an interruption of
the Working Party recognised that there is a need to define donor supply or manufacturing process occurs, an example of
the longest period the donor can donate without testing to which was observed during the recent pandemic. There is a
ensure that safety of the recipient is not compromised. The need for studies to determine the time thresholds and optimal
Working Party agreed that this period should be no longer conditions in which FMT products need to be processed and
than 4 months. Bookend testing could include testing of used. The determination of appropriate storage temperatures
pooled aliquots of donor stool used for manufacturing FMT. is also important for cost-effectiveness and environmental
FMT could only be considered for release from quarantine considerations. Previous BSG/HIS guidelines [3] found mostly
once results have been demonstrated to be clear. low-quality evidence in relation to stool processing and stor-
e Bookend assessment and/or testing of donor to identify risk age. Based on standard practice, they recommended that
factors for pathogen acquisition since baseline screening. stools should be processed within 6 h of defecation, stored
The exact framework should be defined by local policies at 80 C and used within 6 months of processing.

Please cite this article as: Mullish BH et al., The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides
difficile infection and other potential indications: second edition of joint British Society of Gastroenterology (BSG) and Healthcare Infection
Society (HIS) guidelines, Journal of Hospital Infection, https://doi.org/10.1016/j.jhin.2024.03.001
16 B.H. Mullish et al. / Journal of Hospital Infection xxx (xxxx) xxx
Fresh versus frozen stool severity of adverse events of FMT for CDI. The literature from
Effect on success rates: there was moderate evidence which the excluded studies suggests that anaerobic process and
suggested that fresh and frozen stools are equally effective freezing the products have an effect on the viability of the
[19,21,27,28,69]. microbiota, but there still seems to be an adequate clinical
Effect on adverse events: there was weak evidence which effect regardless of these findings. In terms of efficacy, it is
suggested that this does not influence the effectiveness of FMT currently not known how long fresh stools can be kept before
[29]. they are processed and how long the FMT products can be
stored frozen. However, the literature suggests that up to
Stool frozen at 20 C vs 80 C 180 min before processing starts and up to 12 months of storage
Effect on success rates: there was weak evidence which time are acceptable. Due to a relatively low impact on effec-
suggested that this does not influence the effectiveness of FMT tiveness, the Working Party suggested that other factors such
[94]. as overall safety, cost-effectiveness, convenience and envi-
Effect on adverse events: there were no studies. ronmental concerns should be considered when preparing and
storing FMT products. It is preferred that the products are
Lyophilised stool stored frozen because this provides convenience and additional
Effect on success rates: there was weak evidence which safety, as the delay in administration allows more time to
suggested that this does not influence the effectiveness of FMT withdraw faeces if a donor becomes ill or tests positive for a
[95e97]. transmissible pathogen. Current practice in much of the UK is
Effect on adverse events: there was weak evidence which to start the processing of the stools as soon as possible and no
suggested FMT from lyophilised stools is safe [96]. longer than within 150 min from the time of defecation to
freezing. The Working Party stated that there is no reason to
Type of capsule challenge this practice. A threshold of 150 min is used within a
Effect on success rates: there was weak evidence which number of studies, reflecting a balance between enough time
suggested that this does not influence the effectiveness of FMT to pragmatically transfer stool from production by donor to an
[98]. FMT laboratory, and yet a short enough time to mitigate
Effect on adverse events: there were no studies. alterations to microbiome composition and functionality [104].
Either aerobic or anaerobic process is acceptable, and in line
Processing time with standard practice, cryoprotectant needs to be added.
Effect on success rates: there was weak evidence which Additionally, the Working Party reported that many centres in
suggested that processing time for 150 min or longer does not the UK and in mainland Europe have successfully used older
influence the effectiveness of FMT [23,99]. products and they concluded that the storage time of the fro-
Effect on adverse events: there were no studies. zen FMT products can be extended from 6 to 12 months and
that the temperature of the freezer can be increased to 70 C
Storage time to minimise the environmental impact. It is currently not
Effect on success rates: there was weak evidence which known whether the products could be stored at 20 C for up to
suggested that storing frozen products for more than a year 12 months. The Working Party expressed concerns that storage
may not influence the effectiveness of FMT [23,94,99]. at this temperature could result in the loss of bacterial counts,
Effect on adverse events: there were no studies. and therefore recommended that this practice should be
avoided until there is more evidence to support it. Since the
Additional data from excluded studies FMT needs time to be thawed, and there is a concern that the
Anaerobic versus aerobic processing. Two studies [93,100] microbial cultures will start to deteriorate, the Working Party
reported that processing the stool samples under anaerobic recommended that this is done in an ambient temperature and
conditions helps to preserve microbial diversity [93] and via- used within 6 h of thawing. The Working Party also agreed that
bility. [100] On the other hand, one study [101] reported that thawing in water baths should be avoided because this may
oxygen-free atmosphere was not necessary as long as the air lead to contamination of FMT with waterborne pathogens. The
above collected samples was removed. decision whether and how stools should be encapsulated or
lyophilised can be left to individual laboratories and will
Effect of freezing. Two studies [93,102] reported that freezing depend on the availability of the equipment.
resulted in the loss of microbial diversity of the processed stool The Working Party agreed to provide the advice in line of the
samples. One study [102] reported that preparation in recommendations from the previous edition of the guidelines
maltodextrin-trehalose solutions, storage at 80 C standard [3], which suggested, based on data from two systematic
freezer and rapid thawing at 37 C provided the best results for reviews, that 50 g of stool should be used for FMT. Previous
the samples to retain their revivification potential. The same edition of the guidelines also recommended that stools should
solution was also reported to be effective in preserving be mixed with 1:5 proportion to a diluent. However, the
lyophilised samples [101]. Working Party also agreed that these should be considered as
arbitrary figures, not currently supported by the evidence.
Emulsion process. One study [103] showed that magnet plate Thus, FMT processing facilities may choose to adjust this vol-
emulsion and Seward Stomacher Emulsion were similar in terms ume and proportion depending on a clinical need and the
of maintaining microbial load. availability of the donor stools. While the bottom limit for the
The Working Party concluded that there is currently no volume of the stool to be used has not yet been established, it
evidence to suggest that any preparation factors in particular has been acknowledged that some FMT centres use 30 g of
have an effect on the effectiveness or the incidence and stools diluted to 1:6 ratio, and this is still clinically effective.

Recommendations
4.1: Frozen FMT must be offered in preference to freshly processed products.
4.2: Process stools aerobically or anaerobicallydboth methods are acceptable.
4.3: Store prepared FMT products frozen at 70 C for up to 12 months.
4.4: Add cryoprotectant such as glycerol to frozen FMT products.
4.5: If capsules are used, these can be obtained from frozen or lyophilised faecal slurry.
GPPs
GPP 4.1: Follow a standard protocol for stool collection.
GPP 4.2: Start processing stools within 150 min of defecation.
GPP 4.3: When possible, use at least 50 g of stool in each FMT preparation.
GPP 4.5: Use sterile 0.9% saline as a diluent for FMT production.
GPP 4.5: Mix a minimum of 1:5 stool with diluent to make the initial faecal emulsion.
GPP 4.6: Consider homogenisation and filtration of FMT in a closed disposable system.
GPP 4.7: Consider thawing frozen FMT at ambient temperature and using it within 6 h of thawing.
GPP 4.8: Avoid thawing FMT in warm water baths, due to the risks of cross-contamination with Pseudomonas spp (and other
contaminants) and reduced bacterial viability.
GPP 4.9: Where glycerol is used as a cryopreservative, ensure it is at 10e15% final concentration of the prepared faecal material/slurry,
with vortexing or other methods used to fully mix the cryopreservative into the material.

Route of delivery and other administration factors Effect on adverse events: there was very weak evidence
influencing the outcome of FMT for patients with CDI which suggested that delivery via enema had no effect on
adverse events when compared with other administration
FMT can be delivered via the upper and lower gastrointestinal routes [42,108].
tract, allowing it to reach different parts of the digestive tract.
Different delivery routes may have different rates of success but Lower gastrointestinal (unspecified) versus other method-
are also associated with different risks and adverse events and s. Effect on success rates: there was very weak evidence which
may therefore not be suitable for all patients. There are also suggested no difference in effect when comparing lower gas-
other factors to consider during FMT administration. It is still not trointestinal tract administration with other methods when
clear whether taking certain medications or undergoing bowel combined [23,27,109].
preparation shortly before FMT could influence its outcome. Effect on adverse events: there was very weak evidence
Previous BSG/HIS guidelines [3] acknowledged that lower and which suggested that delivery via lower gastrointestinal route
upper gastrointestinal tract administration have similar success had no effect on adverse events when compared with other
rates and adverse events and that both could be used if clinically administration routes [109].
appropriate. However, due to the evidence suggesting lower
efficacy associated with enema administration, this route of Upper gastrointestinal versus other methods. Effect on suc-
delivery was only recommended when neither upper gastro- cess rates: there was weak evidence which suggested no dif-
intestinal routes, nor colonoscopy, would be considered ference in effect when comparing upper gastrointestinal tract
appropriate. Additionally, at the time of publication, there was administration with other methods when combined
a paucity of evidence regarding encapsulated FMT; thus, no [19,21,23,25e27,105,106,109,110].
recommendations were made regarding its use. Regarding other Effect on adverse events: there was weak evidence which
factors, the evidence was low, but the guidelines suggested the suggested that upper gastrointestinal tract administration had
use of bowel lavage and a single dose of antimotility agent if FMT no effect on adverse events when compared with other
was to be delivered via lower gastrointestinal route, and the use administration routes [25,105,106,109].
of PPIs and prokinetics when FMT was administered via the
upper gastrointestinal tract. Oral capsules versus other methods. Effect on success rates:
there was weak evidence which suggested no difference in
Route of delivery effect when comparing oral capsules with other delivery
Colonoscopy versus other methods. Effect on success methods when combined [21,26,38,95,105e109].
rates: there was moderate evidence which suggested that a Effect on adverse events: there was weak evidence which
colonoscopic route may be slightly more effective when suggested that oral capsules had no effect on adverse events
compared with other administration routes combined when compared with other administration routes
[19,21,25,26,38,39,95,105,106]. [38,43,44,105,106,109].
Effect on adverse events: there was weak evidence which
suggested colonoscopic delivery has no effect on adverse Bidirectional (upper and lower gastrointestinal simulta-
events [25,38,106]. neously) versus other methods. Effect on success
rates: there was very weak evidence which suggested a
Enema versus other methods. Effect on success rates: there potential benefit when comparing bidirectional method
was inconsistent evidence but it suggested that enema may be of FMT administration with other routes when combined
less effective than other methods [26,107,108]. [105].

GPPs
5.1: Choose any route of FMT delivery but, if possible, avoid enema.
5.2: When choosing the route of delivery, consider patient preference and acceptability, cost and the impact on environment.
5.3: Consider enema for patients in whom other FMT delivery methods are not feasible.
5.4: There is no need to administer PPIs or other antisecretory agents as a preparation for FMT.
5.5: Do not use antimotility agents as a preparation for FMT.
5.6: Use bowel preparation/lavage as a preparation for FMT.
5.7: After upper gastrointestinal tract administration is used, remove the tube following the flushing with water.

5.8: For patients at risk of regurgitation or those with swallowing disorders, avoid administration via upper gastrointestinal tract and
deliver FMT via lower gastrointestinal tract instead.
5.9: If colonoscopic administration is used, ensure that the FMT is delivered to a site that will permit its retention.
GPPs
GPP 5.1: Use polyethylene glycol preparation as a preferred solution for bowel lavage.
GPP 5.2: Consider using prokinetics (such as metoclopramide) prior to FMT via the upper gastrointestinal tract route
GPP 5.3: Follow best practice for prevention of further transmission of C. difficile when administering FMT to patients.
GPP 5.4: Consider a washout period of at least 24 h between the last dose of antibiotic and treatment with FMT.
GPP 5.5: If upper gastrointestinal tract administration is used, nasogastric, nasoduodenal or nasojejunal tube, upper gastrointestinal
endoscopy or a permanent feeding tube may be used for delivery.
GPP 5.6: If upper gastrointestinal tract administration is used, administer no more than 100 mL of FMT to the gastrointestinal tract.

Post-FMT factors influencing the outcome of FMT for decision needs a formal assessment and a discussion with
patients with CDI infection specialists or other appropriate specialist health-
care professionals. Currently, there is no reason to suspect
The risk factors for failure after administration of FMT, that factors other than post-FMT antibiotics are risk factors
especially associated with the use of antibiotic therapy, for FMT failure.

Recommendations
6.1: Wherever possible, avoid using non-CDI antibiotics for at least 8 weeks after FMT.
6.2: Consult infection specialists or other appropriate healthcare professionals (eg, gastroenterologists with experience of FMT) for
advice whenever FMT recipients have an indication for long-term antibiotics or have an indication for non-CDI antibiotics within
8 weeks of FMT.

started to emerge at the time the first BSG/HIS guidelines [3] Prophylactic FMT treatment to prevent CDI
were about to be published. The guidelines identified two
studies which mentioned a potential link between the Prophylaxis has become one area of interest in CDI more
administration of non-CDI antibiotics in a short time after the broadly and FMT is proposed as a potential therapy among
FMT was given, and subsequently suggested that antibiotic other more traditional agents such as vancomycin and pro-
therapy should ideally not be administered within the first biotics [112] Although no studies were identified, the recog-
8 weeks, and that an infectious disease specialist or a medical nition has grown that CDI pathogenesis relates to gut
microbiologist should be consulted before the therapy is microbiome disruption [113]; therefore, there is a biological
given. Other potential factors (eg, diet or the use of pro- rationale that restoration of gut microbiome in vulnerable
biotics) have also been discussed but their influence on FMT patients (eg, patients with extensive exposure to antibiotics)
outcome remains unclear. via FMT could be a reasonable strategy to prevent CDI. Current
debate also focuses on the definition of prophylaxis, specifi-
Use of non-CDI antibiotics cally whether it should describe the prevention of recurrence
Effect on success rates: there was weak evidence which or the prevention of new CDI in patients at risk. Previous BSG/
suggested a potential negative effect on the effectiveness of HIS guidelines did not address this topic and thus, no recom-
FMT [19,22,23]. mendations were made.
Effect on adverse events: there were no studies. No studies were found in the existing literature which
assessed the effect of prophylactic treatment on any of the
Other post-FMT factors included outcomes.
Effect on success rates: there was very weak evidence which
suggested these do not influence the effectiveness of FMT Additional data from excluded studies
[15,22,23]. The Working Party is aware of one ongoing trial which aims
Effect on adverse events: there were no studies. to evaluate the effectiveness of FMT (oral capsules) for the
The Working Party agreed that there is a concern, prevention of CDI in patients with a history of CDI currently
although evidence is weak, that post-FMT, non-CDI anti- taking antibiotics [114].
biotics are a potential risk factor for FMT failure. As such, the Due to the lack of existing evidence, the Working Party
Working Party recommended that for patients who require agreed that no recommendation can be made in favour or
antibiotics, either long-term or within 8 weeks of FMT, this against prophylactic FMT. Instead, the Working Party suggests

Recommendation
7.1: No recommendation
GPP
GPP 7.1: None

FMT for non-CDI indications Effect on adverse events: there was weak evidence which
suggested that FMT does not have an effect on the adverse
In current clinical practice, FMT is only recommended for events in this group of patients [129,130].
the treatment of recurrent CDI. Due to its success with CDI,
FMT has been investigated for other diseases in which the gut Irritable bowel syndrome
microbiota has been implicated as a pathogenic agent. Pre- Effect on success rates: there was inconsistent evidence,
vious BSG/HIS guidelines [3] reported that the majority of the and it was not possible to determine the effectiveness of FMT
studies investigating the effectiveness of FMT for non-CDI on achieving IBS remission [120,125,127,131e143].
indications were of poor design and quality, and that only a Effect on adverse events: there was strong evidence which
small number of RCTs existed. The conditions which were suggested that FMT does not have an effect on the adverse
reported in the previous guidelines included ulcerative colitis, events in this group of patients [131e133].
IBS, hepatic encephalopathy and metabolic syndrome, all of Effect on quality of life: there was moderate evidence
which showed a potential benefit. However, the lack of evi- which suggested that IBS may improve quality of life for
dence regarding the choice of suitable patients and the most patients with IBS [131e133].
appropriate methods for FMT preparation and administration Additional data from excluded studies: one review [139]
led the Working Party to a decision not to recommend FMT in suggested that while FMT may not show an overall advantage,
the context other than research. At the time the guidelines the delivery via upper gastrointestinal (via duodenoscopy or
were published, it was also noted that there were ongoing trials nasojejunal tube) may be more effective than the delivery via
for other conditions. Since then, more diseases have now been other methods.
linked with the gut microbiome, and a large number of sys-
tematic reviews and meta-analyses investigating the effec- Constipation
tiveness of FMT for these conditions have become available. Effect on success rates: there was weak evidence which
suggested FMT is effective in improving symptoms in patients
Ulcerative colitis with functional constipation [144].
Effect on inducing remission: there was moderate evidence Effect on adverse events: there were no studies.
which suggested FMT is effective in inducing remission in Effect on quality of life: there was weak evidence which
patients with ulcerative colitis [115e125]. suggested FMT may improve the quality of life in patients with
Effect on adverse events: there was strong evidence which constipation [144].
suggested that FMT does not have an effect on the adverse
events in this group of patients [115e117]. Preventing hepatic encephalopathy in patients with
Additional data from excluded studies: one study [126] decompensated cirrhosis
reported that patients who received FMT and also followed an Effect on success rates: there was weak evidence which
anti-inflammatory diet were more likely to achieve remission suggested FMT is effective in preventing hepatic encephalop-
at 8 weeks when compared with patients who received stand- athy [145,146].
ard care. Effect on adverse events: there was weak evidence which
Another study [127], which assessed the effectiveness of suggested a possible negative effect of FMT on adverse events
FMT as a maintenance therapy for patients with ulcerative in this patient group [145].
colitis in remission, reported that 12 months after the inter-
vention, the incidence of remission was similar in a group of Metabolic syndrome
patients who received FMT from a healthy donor and those who Effect on success rates: there was weak evidence which
received autologous FMT. suggested that FMT had no effect on improving biomarkers of
metabolic syndrome [147,148].
Crohn’s disease Effect on adverse events: there were no studies.
Effect on success rates: there was weak evidence which Additional data from excluded studies: four RCTs [149e152]
suggested FMT is effective in maintaining remission in patients reported no improvements in most of the markers associated
with Crohn’s disease [128]. with metabolic syndrome.
Effect on adverse events: there were no studies.

Recommendations
8.1: Do not offer FMT routinely to patients with indications other than CDI.
8.2: Consider FMT on a case-by-case basis for patients with ulcerative colitis in whom licensed treatment options have failed or for those
who are not suitable for currently available treatments.
GPP
GPP 8.1: None

that the treatment with oral antibiotics temporary decreased Compassionate use of FMT
the richness and diversity of gut microbiota but that after the
administration of FMT, the proportion of Enterobacteriaceae While clinical trials are a preferred option for accessing
decreased. One review [160] reported that decolonisation unlicensed medicinal products, this is not always possible. This
rates after FMT ranged from 20% to 90% for different types of may be because a patient may be too ill to enter a clinical trial,
microorganisms, but it reported that the spontaneous clear- fails to meet some aspects of inclusion criteria or that no trial is
ance was not considered in the studies. ongoing at the time the treatment is needed. For this reason,
compassionate use programmes (also known as early access or
Alcoholic hepatitis. One RCT [161] reported that at 28 days special access) were developed to provide access to unlicensed
and 90 days of follow-up, patients who received FMT and treatments [167]. These treatments may include products
antibiotics had higher rates of survival and that hepatic ence- which are still in clinical development or those that are already
phalopathy and ascites resolved in more patients in this group. licensed in other countries. Examples of compassionate use
Another RCT [162] reported that there was a lower rate of 90- programmes include Expanded Access Program in the USA,
day survival in patients who received prednisolone (34 of 60, Compassionate Use Program (for a group of patients with a
57%) when compared with those who received FMT (45 of 60, specified condition) and Named Patient Program (NPP, for
75%, P¼0.044). named patients) in the EU and Early Access to Medicines
The Working Party reviewed the above evidence and Scheme (EAMS) in the UK [168]. The EAMS is available for
concluded that FMT cannot currently be recommended as a manufacturers to apply for the early access to their products;
treatment of conditions other than CDI. The evidence indi- however, another scheme, The Supply of Unlicenced Medicinal
cates that patients with ulcerative colitis may benefit from Products (‘specials’), allows the clinicians to request the

Recommendations
9.1: Consider offering compassionate use of FMT in non-CDI settings only when a patient cannot be entered into a clinical trial and after
discussion and approval in an MDT setting.
9.2: When offering compassionate use of FMT, the following conditions must be met:
e There is a biological rationale to justify consideration.
e Patient is at risk of significant clinical compromise due to a limited alternative range of therapeutic options.
e Patient understands the risks and benefits of FMT compared with other treatment options.
9.3: Prior to treatment, define what will be considered as a success or failure of FMT.
9.4: Prior to treatment, agree potential strategy for further FMTs based on initial clinical success.
GPP
GPP 9.1: None

e There was a reasonable case from published literature to Self-banking of stool for potential future autologous
support a contribution of the gut microbiome to patho- FMT
genesis of the condition, and at least some published data
relating to safety and efficacy of FMT in either a preclinical The Working Party members reported that, in the past, they
or clinical setting for this condition. have been contacted by other clinicians and by patients
e The patient had been unresponsive to/was not suitable for enquiring about banking their own stool with a view to potential
a range of conventional treatment options for their future autologous FMT. One such scenario might be a patient

Recommendation
11.1: Centres that manufacture and dispense FMT must adhere to any regulations applicable to the area in which they are located.
GPP
GPP 11.1: None

not reach the same status on pathogen screening as healthy Further research
donor faecal material conventionally prepared into FMT. Other
outstanding issues related to the regulatory framework which As highlighted above, there are gaps in the evidence for
might govern this process, and/or potential funding arrange- almost every topic presented in these guidelines. While the list
ments and cost-effectiveness of such an approach. As such, the is not exhaustive, the Working Party made some recom-
Working Party concluded that while self-stool banking was of mendations for research which they thought represented cur-
potential interest, it could not be currently advocated. How- rent research priorities.
ever, this can be considered as a concept for further studies.

Recommendation
10.1: Do not routinely self-bank stool from faecal material donated by patients or healthy people for potential future autologous FMT.
GPP
GPP 10.1: None

Research recommendations (RRs)

RR 1: Studies which investigate the effectiveness and cost-effectiveness of FMT for a first episode of CDI.
RR 2: Studies which investigate potentially modifiable patient risk factors which, if corrected, can optimise the outcome of FMT, for
example, genetics, gut microbiota composition or functionality (eg, via metabolomics), immunological status.
RR 3: Studies which investigate donor characteristics that determine the success or failure of FMT.
RR 4: Studies which investigate preparation and storage times beyond those currently recommended.
RR 5: Studies which investigate the highest temperature at which FMT preparations can be stored and for how long.
RR 6: Studies which investigate the optimal methods for capsule preparation.
RR 7: Studies which investigate the best regimen for administration of oral capsules (ie, how many, over how many days, etc).
RR 8: Studies which investigate the clinical utility, feasibility and cost-effectiveness of prophylactic FMT.
RR 9: RCTs which establish the effectiveness and cost-effectiveness of FMT for induction of remission as well as the maintenance of
remission of ulcerative colitis compared with licensed treatment options.
RR 10: Studies which compare different types of FMT protocols for the management of ulcerative colitis.
RR 11: RCTs which investigate the effectiveness and cost-effectiveness of FMT for treatment of constipation using well-established,
objective outcome measures.
RR 12: Larger RCTs which establish the effectiveness and cost-effectiveness of FMT for the management of patients with Crohn’s
disease.
RR 13: Studies which establish which subgroups of patients with IBS may benefit from FMT.
RR 14: RCTs which establish the effectiveness and cost-effectiveness of FMT for treatment, management or prevention of other
conditions, including metabolic syndrome, autism spectrum, pouchitis, hepatic encephalopathy and colonisation with multidrug-
resistant microorganisms.
RR 15: Studies which evaluate the effectiveness, feasibility and cost-effectiveness of using self-bank stools for potential future
autologous FMT.
RR 16: Studies which investigate whether microbiological screening of donors for pathogens with low prevalence in healthy individuals is
needed/justified.
RR 17: Studies which investigate whether FMT has a role in reducing antibiotic use and thus reducing the development of resistance to
existing antibiotics.
RR 18: Avoid producing duplicate reviews, that is, where the evidence has recently been reviewed in a peer-reviewed journal and there
is no new evidence to change the conclusions.

Further considerations: next-generation FMT also impact upon the ability to use FMT within a UK research
and novel microbiome therapeutics setting, where there is currently highly active clinical and
translational research activity.
The Working Party discussed several microbiome ther- The Working Party concluded that there was a clear need for
apeutics, which have evolved from FMT, and are at various ongoing dialogue between entities developing novel micro-
stages of development and clinical trials. There are several biome therapeutics, academic and hospital centres providing
different approaches being used, including full spectrum FMT, and regulators to ensure no interruption at any point in
microbiome products (which have the most direct com- provision of therapy to eligible patients with CDI, and that
parability with conventional FMT), as well as products involving clinical and translational FMT/microbiome therapeutics
particular microbiome components (eg, spore-based therapies research in this field in the UK remains globally competitive.
or defined microbial consortia). At the time of writing, two The Working Party concluded that the following topics are
microbiome therapeutics have been approved by the US FDA now resolved and should not be included for an update in the
for prevention of CDI relapses, namely RBX2660/Rebyota future editions of the guidelines:
(Ferring; a rectally administered FMT-type product [8]) and
SER-109/Vowst (Seres/Nestle; a purified spore-based product 1. Effectiveness of FMT for recurrent CDI versus anti-CDI
[9]); no such products have been licensed for the use in any antibiotics/placebo in the general population. This topic
non-CDI indication. can be revisited if new therapies, more effective than
The Working Party discussed their expectation that several current antibiotic treatment, become available. Topics in
early and late-phase clinical trials involving such products were relation to patients with different conditions and factors
ongoing globally, and there was a reasonable expectation of related to CDI infections (eg, severity, first occurrence)
applications for licensing for use within the UK within the should still be investigated.
lifespan of this guideline. If such licensing was granted, there 2. Non-modifiable recipient factors, for example, age. Cur-
would be clear implications for use of ‘conventional’ FMT rent evidence suggests that these factors do not reduce the
within the UK. For instance, licensing of a microbiome ther- effectiveness of FMT to the point where recommendations
apeutic for use in recurrent CDI would potentially negate the would change. Future studies need to focus on identifying
ability to supply FMT under a UK specials licence, given that modifiable recipient and donor factors, optimising FMT
FMT is an unlicensed medicinal product. This may potentially administration and preventing CDI recurrence after FMT.

Please cite this article as: Mullish BH et al., The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides
difficile infection and other potential indications: second edition of joint British Society of Gastroenterology (BSG) and Healthcare Infection
Society (HIS) guidelines, Journal of Hospital Infection, https://doi.org/10.1016/j.jhin.2024.03.001
B.H. Mullish et al. / Journal of Hospital Infection xxx (xxxx) xxx 25
Author contributors Appendix A. Supplementary data
DJM helped design literature strategy. BHM, BMerrick, MNQ
and AB screened the literature. AB conducted searches, Supplementary data to this article can be found online at
performed initial data extraction and evidence syntheses, https://doi.org/10.1016/j.jhin.2024.03.001.
which were checked by BHM, BMerrick and MNQ. All authors
except AB also provided advice. BHM, BMerrick, MNQ and AB
wrote the first draft. BHM, BMerrick, MNQ, AB, CAG, DJM, References
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Gastroenterology (BSG) and Healthcare infection society (HIS)
Pharmaceuticals, Finch Therapeutics, Summit Therapeutics
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Please cite this article as: Mullish BH et al., The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides
difficile infection and other potential indications: second edition of joint British Society of Gastroenterology (BSG) and Healthcare Infection
Society (HIS) guidelines, Journal of Hospital Infection, https://doi.org/10.1016/j.jhin.2024.03.001
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sion in inflammatory bowel disease: a systematic review and bowel syndrome: a meta-analysis of randomized controlled tri-
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ized clinical trial. JAMA 2019;321:156e64. exploring the role of fecal Microbiota transplantation in irrita-
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study. Microbiome 2020;8:12. constipation in adults: a systematic review and meta-analysis of

Please cite this article as: Mullish BH et al., The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides
difficile infection and other potential indications: second edition of joint British Society of Gastroenterology (BSG) and Healthcare Infection
Society (HIS) guidelines, Journal of Hospital Infection, https://doi.org/10.1016/j.jhin.2024.03.001
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Prophylactic FMT treatment to prevent CDI

Scheduled review General population with CDI

e Clostridioides difficile tcdB (toxin B) by PCR*

Research recommendations (RRs)

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