III. FMT Treatment Protocol

III. 3 The FMT Procedure

Knowing what to expect is part of the treatment: this chapter walks through each delivery method and what sensations count as normal.

Knowing What to Expect Is Part of the Treatment

Anecdote

In the late nineteenth century, blood transfusion was practiced sporadically and with alarming inconsistency: some patients recovered; others died within hours. Physicians could not predict which outcome would follow. The explanation arrived in 1901, when Karl Landsteiner, a thirty-three-year-old pathologist at the University of Vienna, published a paper demonstrating that human blood could be grouped into distinct types – what he called A, B, and C (later renamed O). Transfusing blood of the wrong type caused the recipient's immune system to recognise the incoming cells as foreign and destroy them. The reaction could be fatal. Landsteiner received the Nobel Prize in Physiology or Medicine in 1930. His discovery made transfusion medicine safe by establishing a single principle: before anything is transferred between bodies, the compatibility of the recipient's biology with what is being introduced must be assessed. FMT rests on the same principle, applied to a far more complex biological material than blood. A donor community that is immunologically or ecologically mismatched with the recipient does not fail quietly. It produces a response – and understanding what that response means is the starting point for every procedure described in this chapter.

The FMT procedure is not a single, uniform event. Depending on the delivery route, the patient's diagnosis, and the phase of treatment, the experience will differ significantly. What is consistent across all formats is that the procedure is designed to be safe, minimally invasive, and reproducible. Understanding what will happen – and what sensations and responses are normal – can, in line with general patient-education principles, reduce anticipatory anxiety and support adherence to the treatment plan [468].

This chapter describes the procedural experience from the patient's perspective for each delivery format used in FMT practice: colonoscopic delivery, capsule-based oral FMT, and retention enema. The focus is on what the patient will experience directly – before, during, and immediately after each procedure type – alongside the clinical rationale for each step. Specific warning signs that require immediate medical contact are addressed in detail in Chapter II.4.

Colonoscopic FMT – The High-Dose Induction Procedure

Colonoscopic FMT is the highest-dose delivery method currently in clinical use. It is typically reserved for Phase 1 induction in recurrent Clostridioides difficile infection and in selected non-CDI patients requiring rapid and deep microbial community seeding. The procedure follows the same general framework as a diagnostic colonoscopy and is performed by a gastroenterologist or colorectal specialist in an endoscopy unit.

Before the procedure. The patient will have completed bowel preparation as described in Chapter II.2. On arrival at the endoscopy unit, a brief clinical assessment is performed: vital signs are recorded, any changes in symptoms or medications since the last clinical contact are noted, and written informed consent is confirmed. An intravenous cannula is typically placed for sedation access. The patient changes into a procedure gown and is positioned in left lateral decubitus on the procedure table. Light to moderate conscious sedation – most commonly with midazolam and fentanyl, or propofol depending on local practice and patient preference – is administered by an anaesthetist or trained endoscopy nurse [751]. The patient remains conscious and responsive but is typically relaxed and experiences little or no discomfort during the procedure itself.

During the procedure. The colonoscope is advanced through the entire colon to the caecum and terminal ileum under direct visualization. The total insertion time is typically 10–20 minutes. Once the colonoscope is positioned at the caecum, the FMT preparation – a processed, filtered donor stool suspension in normal saline (or, for frozen preparations, in thawed glycerol cryoprotectant) – is infused through the working channel of the colonoscope as the instrument is slowly withdrawn. The European consensus recommends at least 30 g of stool per procedure, diluted with three to five volumes of solvent; a suspension of 200–500 mL can be safely delivered into the colon [016], [447]. The infusion is distributed across the right colon, transverse colon, and left colon during withdrawal, maximizing mucosal surface contact and reducing the risk of the preparation pooling in a single segment. The patient typically feels mild cramping or a sense of fullness during infusion, which resolves quickly. Total procedure time from scope insertion to withdrawal is usually 20–40 minutes.

After the procedure. The patient is moved to a recovery area and monitored for 30–60 minutes as the sedation wears off. Vital signs are checked at regular intervals. Mild abdominal discomfort, bloating, or urgency to defecate is common in the first 1–2 hours and is expected: the introduced preparation volume and the mechanical stimulation of the colonoscopy both contribute to increased intestinal activity. Patients are encouraged to retain the preparation for as long as possible after the procedure – the European consensus recommends at least 30 minutes of retention and a supine position to reduce the urge to defecate – to maximize mucosal contact time [016]. A responsible adult must accompany the patient home if sedation was used; driving is not permitted on the day of the procedure. Patients may resume a light normal diet the same afternoon or evening. Patients typically return to their usual daily activities shortly after the effects of sedation have worn off; the pace of post-procedural recovery has not been quantified in dedicated studies, so no fixed interval can be promised [468], [447].

Capsule-Based Oral FMT – The Repeated-Dose Protocol

Oral capsule FMT is the primary delivery format for the compatibility assessment phase (Phase 0), the consolidation phase (Phase 2), and the step-down phase (Phase 3) of the MicroBiome Bank protocol. It is also used for intensive induction in selected patients where colonoscopy is contraindicated or not preferred. Capsules contain lyophilized donor microbiota and, swallowed whole, deliver their contents to the small intestine and colon [008], [469].

Before taking capsules. No fasting or bowel preparation is required. Under the MicroBiome Bank protocol, the patient should eat a regular meal before taking the capsules; the aim is to provide fermentable substrate for the microbiota as it is released. This step is an institutional practice recommendation, not a published trial result. Water intake of at least 200–300 mL should accompany capsule ingestion to support capsule transit and hydration of the lyophilized preparation. Patients should avoid taking the capsules immediately before lying down, as recumbent posture slows gastric emptying and may delay small intestinal delivery.

Taking the capsules. The prescribed number of capsules – which varies by phase and individual protocol – should be taken in one sitting with the prescribed quantity of water. Capsules should not be opened, chewed, or dissolved before swallowing: the integrity of the capsule is integral to the delivery mechanism and its disruption would expose the microbial content to gastric acid, dramatically reducing viability [008]. If swallowing multiple capsules is difficult, the patient may take them in two or three smaller groups over 10–15 minutes; each group should be accompanied by a full glass of water. Some patients experience mild nausea when taking larger capsule doses; this is transient and usually resolves within 30–60 minutes. If nausea is severe or accompanied by vomiting, the clinical team should be notified, as vomited capsules cannot be replaced without clinical assessment.

After taking capsules. Normal activities may be resumed immediately. No rest period is required. In Phase 0, patients should begin or continue their Food and Symptom Diary entries from the same day: stool changes, abdominal symptoms, energy level, and any unusual sensations should be recorded daily. Changes in stool frequency, colour, or consistency in the first days following capsule intake are common and typically reflect the initial ecological response to the donor preparation rather than pathological processes. Stool may appear looser, darker, or more frequent than baseline during this period; mild, self-limiting gastrointestinal symptoms are the most common FMT-associated adverse effects and are not warning signs, provided no blood is present and the patient is not systemically unwell [015], [470].

Retention Enema FMT – Lower Bowel Delivery

Retention enema delivery of FMT is used in specific clinical contexts: as a maintenance format in selected ulcerative colitis patients, in patients for whom colonoscopy is not feasible and capsule tolerance is poor, and occasionally for distal colonic disease where targeted lower bowel delivery is preferred. The enema preparation volume varies between protocols – typically processed donor suspension in the range of tens to a few hundred millilitres – administered via a standard enema catheter inserted rectally; the European consensus recommends retaining the preparation for at least 30 minutes after instillation [016], [447].

The procedure. The patient lies in left lateral decubitus position with knees drawn up. A lubricated catheter is gently inserted approximately 10–15 cm into the rectum. The suspension is slowly instilled by gravity or gentle manual pressure over 2–5 minutes. The catheter is removed and the patient is asked to retain the preparation for a minimum of 30 minutes, ideally 1–2 hours. Longer retention times are associated with higher proportional colonic distribution of the preparation and improved clinical outcomes [464]. To assist retention, the patient may change position during the retention period – moving from left lateral to supine to right lateral at 10–15 minute intervals has been shown to improve distribution through the left colon and splenic flexure. Mild urgency to defecate is expected and can usually be suppressed with relaxation and positional adjustment; if urgent defecation occurs before 20–30 minutes, the clinical team should be notified.

Efficacy evidence – the role of the delivery route. The systematic review and meta-analysis by Ramai et al. (2021) compared delivery routes in recurrent C. difficile infection (rCDI): colonoscopic FMT proved superior to retention enema and nasogastric tube delivery, while producing results comparable to capsule FMT [009]. This supports patient-tailored decision-making – based on patient preference as well as clinical factors – when selecting the delivery route: where colonoscopy is not feasible, the capsule route is an alternative without meaningful loss of efficacy, whereas enema and upper gastrointestinal delivery fall short of these in rCDI.

Procedural Comparison – What the Patient Experiences

AspectColonoscopic FMTOral Capsule FMTRetention Enema FMT
SettingHospital endoscopy unit; day procedure or inpatient admission requiredHome; no clinical supervision requiredHome; no clinical supervision required
PreparationBowel preparation (PEG solution day before/morning of); liquid diet 24 h; sedation or anaesthesiaNo fasting, no bowel preparation; meal recommended before capsule intakeNo full bowel preparation; spontaneous defecation before the procedure is advisable
ProcedureSedation; colonoscope advanced to caecum; suspension infused via working channel during withdrawal; 20–40 min totalCapsules swallowed with water after a meal; 5–15 minCatheter inserted rectally ~10–15 cm; suspension delivered by gravity over 2–5 min
Sensations during procedureMinimal sensation under sedation; mild cramping during infusion; bloating and fullness on wakingCapsule swallowing; possible mild nausea with larger doses, resolving within 30–60 minMild pressure and fullness during delivery; urge to defecate that must be resisted; cramping in the first 10–20 min
After the procedure30–60 min recovery (sedation); responsible adult escort required; no driving on procedure day; light diet that eveningNormal activities can resume immediately; no restrictionsAim to retain preparation for minimum 30–60 min (ideally 1–2 h); normal activities after retention
Microbial reachFull colon from caecum to rectum; maximum mucosal contact surfaceColon (capsule dissolves in small intestine); altered upper GI microenvironmentRectum and rectosigmoid; limited proximal reach
Typical symptoms in first 24–48 hIncreased stool frequency, loose stool, bloating, mild cramping; overlapping with residual bowel preparation effectsMild bloating, possibly loose stool in first 1–2 days; generally well toleratedMild cramping and increased defecatory urge in the 24 h following retention; loose stool possible

Table 5 – Comparison of FMT delivery routes from the patient perspective # Sensations described are typical; individual experience varies. Any sensation outside the expected range described above should be reported to the clinical team.

What Is in the FMT Preparation – Processing, Safety, and Storage

The donor material used in MicroBiome Bank FMT preparations undergoes a structured multi-step processing protocol before administration. Understanding this process addresses a concern common among patients and supports informed consent.

Donor screening. All MicroBiome Bank donors are healthy adults who have undergone extensive screening including blood tests (HIV, hepatitis B and C, HTLV, syphilis, CMV, EBV), stool cultures (C. difficile, enteric pathogens, ova and parasites, Helicobacter pylori, norovirus, rotavirus, adenovirus), extended pathogen PCR panels, and a detailed health and lifestyle questionnaire. Screening is repeated every 3 months during active donation. This protocol meets or exceeds the standards established in the European Consensus Conference on FMT [016] and the OpenBiome/international stool bank guidelines [474]. Since 2020, SARS-CoV-2 screening has been added to the standard protocol [475].

Processing and formulation. Donated material is processed within a defined time window after collection, typically under anaerobic or reduced-oxygen conditions to maximize viability of obligate anaerobic bacteria – the taxa most critical for SCFA production and colonization resistance. The preparation is filtered to remove particulate matter, standardized for microbial density, and mixed with a cryoprotective medium before lyophilization (freeze-drying) or freezing. Lyophilization (freeze-drying) yields a form that requires a less demanding cold chain than frozen material and can be stored for longer, which is essential for outpatient capsule protocols; the actual shelf life and permitted shipping temperature depend on the stool bank's validated stability data [735]. Frozen preparations are stored at −80°C and thawed immediately before use in colonoscopic or enema procedures.

Safety record. The serious adverse event rate in FMT – defined as events requiring hospitalization, specific medical treatment, or resulting in permanent harm – is low in appropriately screened patients. A 2021 systematic review of 4,241 FMT procedures reported a serious adverse event rate of approximately 1–2%, with the majority attributable to the endoscopic procedure rather than the FMT material itself [015]. Transmission of pathogens not covered by standard screening protocols has occurred in rare instances in the published literature, highlighting the ongoing importance of rigorous and updated donor screening as new pathogen risks emerge. Patients with severe immunosuppression (e.g., post-bone marrow transplant, high-dose corticosteroid use) carry higher procedural risk and receive individualized risk-benefit assessment before FMT is initiated [476].

Microbiota Effects

  • Colonoscopic FMT delivers the largest volume of donor preparation with direct mucosal contact across the entire colonic surface. Comparative clinical data show that the cure rate of colonoscopic delivery in recurrent C. difficile infection exceeds that of enema and nasogastric tube delivery [009]; direct comparisons of microbial density and community-shift kinetics between delivery routes are, however, not available.
  • Capsule-based oral FMT delivers viable microbial communities to the ileum and proximal colon; the purpose of the acid-resistant capsule coating is to protect the microbial content from inactivation by gastric acid. The magnitude of viability loss during gastric transit has not been quantified in a published clinical study; capsule delivery has, however, not proved less effective than colonoscopic delivery in a randomized trial in recurrent C. difficile infection [008].
  • The longest possible retention after enema FMT is the aim of practical protocols, because it increases the mucosal contact time of the preparation and thereby, in principle, improves the chance of microbial attachment and initial colonization; the dose–response relationship between retention time and engraftment has not, however, been quantified in dedicated studies, so no specific time increment can be given [464].
  • Sedation used during colonoscopic FMT does not appear to meaningfully affect engraftment rates; however, opioid-based sedation agents transiently slow intestinal motility, which may extend colonic retention of the infused preparation and potentially benefit post-procedural distribution [447].
  • Anaerobic processing of FMT preparations serves to preserve the microbial viability of the product: the great majority of colonic bacteria are obligate anaerobes and markedly oxygen-sensitive – among them butyrate-producing taxa such as Faecalibacterium prausnitzii[G], Roseburia intestinalis, and Eubacterium rectale – so their numbers may fall or they may be lost altogether when processing is carried out under aerobic conditions. In a randomized, double-blind trial using anaerobically prepared donor material, the rate of remission at week 8 was higher than with autologous FMT [188].
  • Lyophilization (freeze-drying) preserves microbial community composition and viability over extended storage periods, though modest shifts in community composition relative to the fresh original material have been reported; the clinical significance of these shifts for engraftment outcomes is currently being evaluated in comparative trials [008].
  • The donor microbiome's ecological profile – including its diversity, keystone species composition, and bacteriophage community – is transferred to the recipient during the procedure and constitutes the primary determinant of post-FMT community structure; the procedural route modulates the density and spatial distribution of this transfer but does not fundamentally alter which species are introduced [156].

Patient Guidance

  • Before any FMT procedure, confirm with your clinical team exactly what format you will receive (colonoscopy, capsule, or enema), the planned date and time, and any preparation steps that still need to be completed. Do not assume preparation requirements are the same as for a previous procedure.
  • If you are scheduled for colonoscopic FMT: arrange for a responsible adult to accompany you and to drive or escort you home. You will not be permitted to drive on the day of the procedure due to sedation. Plan to be at the endoscopy unit for 2–3 hours in total, including preparation, procedure, and recovery time.
  • If you experience significant anxiety about the colonoscopic procedure, discuss this with your clinical team in advance. Anxiolytics or modified sedation protocols can be arranged if needed; unmanaged anticipatory anxiety reduces cooperation during the procedure and increases the perceived discomfort.
  • For capsule FMT: take your capsules with a full glass of water (200–300 mL minimum), after a regular meal, and do not lie down immediately after ingestion. If you feel nauseous, remain upright and breathe slowly; the sensation typically passes within 30–60 minutes. Do not open or crush the capsules under any circumstances.
  • For retention enema FMT: prepare your environment before the procedure – have towels, a comfortable position, and if possible a clock visible to time your retention period. Start in left lateral position, then slowly rotate to supine and right lateral at 15-minute intervals if you can tolerate it. Aim for the longest retention you can manage; the precise relationship between retention time and effectiveness has not been quantified in studies.
  • In the 24–72 hours after any FMT procedure, expect changes in your stool: looser consistency, darker colour, increased frequency, or increased flatulence are all normal and expected responses reflecting the initial ecological activity of the donor community. These changes do not require treatment and should not alarm you.
  • Record your symptoms in your Food and Symptom Diary starting on the day of the procedure. Note the time you received the preparation, your first post-procedure stool (time, Bristol scale score), any abdominal sensations, your energy level, and what you ate. This record is your clinical team's primary monitoring tool in the days immediately following the procedure.
  • Immediately contact your clinical team – or go to an emergency department – if you develop any of the following after FMT: fever above 38°C, blood in the stool (bright red or dark tarry), severe abdominal pain that is not relieved by normal bowel movements, persistent vomiting, significant worsening of your existing condition beyond the expected initial fluctuation, or any systemic symptoms such as chills, difficulty breathing, or rash. These are addressed in detail in Chapter II.4.
  • Resume normal dietary habits from the day after the procedure, or earlier if you feel well. There is no need for dietary restriction in the days following FMT – maintaining your usual fiber intake is actively beneficial for the incoming donor community. Follow the dietary guidance from Chapter III.1 of this guide.
  • If for any reason a scheduled procedure has to be cancelled or delayed, contact your clinical team to reschedule as promptly as possible. Gaps between phases – particularly between the end of Phase 0 and the start of induction – reduce the continuity of the ecological intervention and may require protocol adjustment.
🦪
Clinical Pearl Colonoscopic delivery to the caecum provides the greatest mucosal contact area and the shortest transit time to the colon's highest microbial density zones. Capsule FMT demonstrates equivalent efficacy to colonoscopy for CDI when sufficient dosing frequency is maintained during the consolidation phase.

References

[008] Kao D, Roach B, Silva M et al. Effect of Oral Capsule– vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium. difficile Infection: A Randomized Clinical Trial. JAMA. 2017. Link

Noninferiority randomized trial in 116 adults with recurrent CDI across three Canadian academic centres comparing oral capsule FMT with colonoscopy-delivered FMT (enrolment 2014–2016; noninferiority margin 15%). The study tested whether less invasive capsule delivery matches colonoscopy in preventing further CDI recurrence. Results support clinical equivalence between routes, enabling broader and lower-burden access to FMT for recurrent CDI.

[009] Ramai D, Zakhia K, Fields PJ, Ofosu A, Patel G, Chang S. Fecal Microbiota Transplantation (FMT) with Colonoscopy Is Superior to Enema and Nasogastric Tube While Comparable to Capsule for the Treatment of Recurrent Clostridioides difficile Infection: A Systematic Review and Meta-Analysis. Digestive Diseases and Sciences. 2021. Link

Systematic review and meta-analysis of whether the delivery route matters in FMT for recurrent C. difficile infection. Twenty-six studies with 1309 patients were drawn from three databases (PubMed, EMBASE, CINAHL): colonoscopy in 16 studies (483 patients), nasogastric tube in 5 (149), enema in 4 (360) and capsules in 4 (301). Pooled cure rates were: colonoscopy 94.8 percent, capsule 92.1 percent, enema 87.2 percent, nasogastric/nasoduodenal tube 78.1 percent. Conclusion: colonoscopic delivery is superior to enema and tube delivery but comparable to capsules — that is, the least burdensome route costs nothing in efficacy. Sample preparation (fresh or frozen) and donor relationship did not affect the outcome.

[015] Marcella C, Cui B, Kelly CR, Ianiro G, Cammarota G, Zhang F. Systematic review: the global incidence of faecal microbiota transplantation-related adverse events from 2000 to 2020. Aliment Pharmacol Ther. 2021. Link

Systematic review of FMT safety summarizing adverse events (AEs) over 20 years from 129 studies including 4,241 patients and 5,688 FMT courses (search of EMBASE, MEDLINE, Cochrane, CNKI, Wanfang from 2000 to 2020). AEs were classified as delivery-related or microbiota-related. The review provides the largest aggregate FMT safety dataset to date and supports the overall favourable safety profile of FMT for recurrent CDI, while flagging that complications may be under-reported in the literature.

[016] Cammarota G, Ianiro G, Tilg H et al. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017. Link

European consensus conference developing evidence-based recommendations on FMT for clinical practice, with 28 experts from 10 countries collaborating in working groups. Statements were generated through evidence-based review, evaluated electronically via a Delphi process, and finalized in a plenary consensus session. Recommendations cover FMT indications, donor selection, faecal material preparation, clinical management, faecal delivery, and minimum requirements for establishing an FMT centre. Provides the European standardization framework for safe and governed FMT delivery.

[156] Ianiro G, Puncochar M, Karcher N, Porcari S, Armanini F, Asnicar F, Segata N. Variability of strain engraftment and predictability of microbiome composition after fecal microbiota transplantation across different diseases. Nat Med. 2022. Link

Integrated shotgun-metagenomic meta-analysis of 226 triads (donor, pre-FMT and post-FMT recipient) across eight different disease types, using improved strain profiling. The key finding: **recipients with higher donor-strain engraftment were more likely to achieve clinical success** after FMT (P=0.017). Engraftment depends on the donor, the delivery route (multi-route — e.g. capsule plus colonoscopy together — gives higher engraftment) and the recipient (higher in antibiotic-treated infectious-disease recipients than in antibiotic-naive noncommunicable-disease patients); Bacteroidetes and Actinobacteria species engraft better. This entry is the source for the IV.3 claim that, because of donor-dependent engraftment variability, an alternative donor lot (LOT switch) can improve the outcome. **LIMITATION:** an observational meta-analysis across eight disease types (not CDI alone), measuring association; it did not study product-LOT switching as such.

[188] Costello SP, Hughes PA, Waters O et al. Effect of fecal microbiota transplantation on 8-week remission in patients with ulcerative colitis: a randomized clinical trial. JAMA. 2019. Link

A multicenter, randomized, double-blind trial in three Australian centers enrolled 73 adults with mild-to-moderate ulcerative colitis. Patients received anaerobically prepared pooled donor FMT (n=38) or autologous FMT (n=35) via colonoscopy followed by 2 enemas over 7 days, with 12-month follow-up. Anaerobic stool processing was hypothesized to enhance microbial viability and allow efficacy with shorter, less intensive FMT therapy. The trial supports anaerobically prepared, short-duration FMT as an effective induction therapy in active UC.

[447] Peery AF, Kelly CR, Kao D et al. AGA Clinical Practice Guideline on Fecal Microbiota-Based Therapies for Select Gastrointestinal Diseases. Gastroenterology. 2024. Link

AGA clinical practice guideline using the GRADE framework to address fecal microbiota-based therapies (conventional FMT, fecal microbiota live-jslm, fecal microbiota spores live-brpk) in adults with recurrent or severe-to-fulminant Clostridioides difficile infection, IBD/pouchitis, and IBS. The panel issued 7 recommendations. In immunocompetent adults with recurrent CDI, the AGA suggests selective use of fecal microbiota-based therapies after standard-of-care antibiotics to prevent further recurrence. Provides framework guidance integrating FDA-approved products with conventional FMT.

[464] Paramsothy S, Kamm MA, Kaakoush NO et al. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017. Link

Paramsothy and colleagues report the FOCUS trial, a landmark Lancet 2017 randomised placebo-controlled study of multidonor intensive fecal microbiota transplantation (FMT) in active ulcerative colitis. Eighty-one adults with mild-to-moderate active UC received either pooled-donor FMT or placebo enemas, with an induction colonoscopic infusion followed by enemas five days per week for eight weeks. The primary endpoint of steroid-free clinical remission with endoscopic remission or response at week 8 was achieved in 27% of FMT versus 8% of placebo recipients (p=0.021). Microbial diversity increased in responders, with specific Fusobacterium decreases and Eubacterium and Roseburia increases. The trial established multidonor, intensive-dose FMT as a credible therapeutic strategy in UC.

[468] Zipursky JS, Sidorsky TI, Freedman CA, Sidorsky MN, Kirkland KB. Patient attitudes toward the use of fecal microbiota transplantation in the treatment of recurrent Clostridium difficile infection. Clin Infect Dis. 2012. Link

Structured survey of 192 patients (48% response rate) assessing willingness to consider FMT for recurrent CDI. Seventy percent of respondents were female and 59% were over 49 years. When given efficacy data only, 162 respondents (85%) chose FMT and 29 (15%) chose antibiotics alone. After learning of the faecal nature of FMT, 16 respondents switched to antibiotics, but the overall FMT preference remained essentially unchanged (154/192, 81%; P=0.15). The findings refute the assumption that aesthetic concerns drive low FMT uptake and support patient willingness when adequately informed.

[469] Ianiro G, Bibbo S, Scaldaferri F et al. Fecal Microbiota Transplantation in Inflammatory Bowel Disease: Beyond the Excitement. Medicine (Baltimore). 2014. Link

Systematic review of FMT in inflammatory bowel disease (IBD), identifying 31 publications — mostly case reports and case series, with 8 open-label trials enrolling small cohorts. A total of 133 IBD patients had been treated with FMT at the time of review. The authors critically appraised effectiveness, safety, and procedural parameters across reports. Findings reflect heterogeneous early evidence with promising but inconsistent signals, supporting the need for adequately powered controlled trials before routine clinical use in IBD.

[470] Staley C, Khoruts A, Sadowsky MJ. Contemporary Applications of Fecal Microbiota Transplantation to Treat Intestinal Diseases in Humans. Arch Med Res. 2017. Link

A review (Staley, Khoruts, Sadowsky, Arch Med Res 2017) on contemporary clinical applications of fecal microbiota transplantation (FMT) for human intestinal diseases. FMT, the transfer of gut microbiota from a healthy donor to restore the diversity and function of the microbial community, has become a well-established alternative therapy for recurrent Clostridium difficile infection. The authors also note that clinical trials and animal models suggest promise for FMT in inflammatory bowel diseases and metabolic syndrome.

[474] Smith MB, Kelly C, Alm EJ. Policy: How to regulate faecal transplants. Nature. 2014. Link

Smith, Kelly and Alm's 2014 Nature policy paper argues for proportionate, science-based regulation of fecal microbiota transplantation (FMT). Writing in the wake of the FDA's enforcement discretion for recurrent CDI, the authors examine whether stool should be regulated as a drug, a tissue, or a new category. They highlight risks of overregulation (driving patients to unsafe DIY procedures) and underregulation (donor screening gaps, off-label expansion). The paper proposes a tiered framework: lighter touch for established indications such as CDI, stricter trial-based oversight for experimental indications, and a unified safety registry. The recommendations have shaped subsequent EU, US and stool-bank regulatory debates.

[475] Ianiro G, Mullish BH, Kelly CR et al. Screening of faecal microbiota transplant donors during the COVID-19 outbreak: suggestions for urgent updates from an international expert panel. Lancet Gastroenterol Hepatol. 2020. Link

A 2020 international expert-panel recommendation: in response to the COVID-19 pandemic, SARS-CoV-2 questionnaire screening and molecular (RT-PCR) testing should be added to stool-donor screening, making SARS-CoV-2 screening part of standard FMT donor protocols from 2020.

[476] DeFilipp Z, Bloom PP, Torres Soto M et al. Drug-Resistant E. coli Bacteremia Transmitted by Fecal Microbiota Transplant. New England Journal of Medicine. 2019. Link

Case report of two patients in independent FMT clinical trials who developed ESBL-producing Escherichia coli bacteremia after the procedure; both cases were linked to the same stool donor by genomic sequencing, and one patient died. Highlights the risk of multidrug-resistant organism transmission via FMT and supports enhanced donor screening protocols. The report underpins regulatory updates requiring multidrug-resistant pathogen screening of all FMT donor material.

[735] Cammarota G, Ianiro G, Kelly CR et al. International consensus conference on stool banking for faecal microbiota transplantation in clinical practice. Gut. 2019. Link

This international consensus from FMT experts in Europe, North America and Australia provides statements on stool banking for FMT, covering general principles, organization, donor selection and screening, stool collection/preparation/storage, services and clients, registries, outcome monitoring, ethics and FMT's evolving clinical role. Consensus was achieved through Delphi rounds plus plenary discussion, with statements supported by best available evidence. The document guides global stool-bank development to promote safe, equitable FMT access for recurrent C. difficile infection.

[751] Early DS, Lightdale JR, Vargo JJ, Acosta RD, Chandrasekhara V, Chathadi KV, Evans JA, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Muthusamy VR, Pasha SF, Saltzman JR, Shergill AK, Cash BD, DeWitt JM. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointestinal Endoscopy. 2018. Link

An evidence-based guideline from the American Society for Gastrointestinal Endoscopy on sedation and anaesthesia in gastrointestinal endoscopy. It states that for routine upper endoscopy and colonoscopy the standard approach to moderate ('conscious') sedation is a benzodiazepine (typically midazolam) combined with an opioid (typically fentanyl or pethidine), and devotes a separate section to the efficacy and safety of propofol sedation, both anaesthesiologist- and non-anaesthesiologist-administered. It covers patient pre-assessment, monitoring requirements (pulse oximetry, capnography), staffing, and identification of patients requiring deep sedation. The guideline was reviewed and endorsed by the AASLD, the ACG and the AGA.

Authors:
PG
Dr. Patay Gábor
physician, microbiota specialist
BA
Dr. Bezzegh Attila
medical director, clinical microbiologist
AM
Dra. Anna Munar
physician, exposome specialist
MicroBiome Bank — medically reviewed professional content. Last updated: 2026.