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Review
. 2023 Apr 25;4(4):CD012774.
doi: 10.1002/14651858.CD012774.pub3.

Fecal transplantation for treatment of inflammatory bowel disease

Aamer Imdad  1 , Natasha G Pandit  2 , Muizz Zaman  2 , Nathan Zev Minkoff  3 , Emily E Tanner-Smith  4 , Oscar G Gomez-Duarte  5 , Sari Acra  6 , Maribeth R Nicholson  6
Affiliations
Review

Fecal transplantation for treatment of inflammatory bowel disease

Aamer Imdad et al. Cochrane Database Syst Rev. .

Abstract

Background: Inflammatory bowel disease (IBD) is a chronic, relapsing disease of the gastrointestinal (GI) tract that is thought to be associated with a complex interplay between the immune system, the GI tract lining, the environment, and the gut microbiome, leading to an abnormal inflammatory response in genetically susceptible individuals. An altered composition of the gut's native microbiota, known as dysbiosis, may have a major role in the pathogenesis of ulcerative colitis (UC) and Crohn disease (CD), two subtypes of IBD. There is growing interest in the correction of this underlying dysbiosis using fecal microbiota transplantation (FMT).

Objectives: To evaluate the benefits and safety profile of FMT for treatment of IBD in adults and children versus autologous FMT, placebo, standard medication, or no intervention.

Search methods: We searched CENTRAL, MEDLINE, Embase, two clinical trial registries, and the reference sections of published trials through 22 December 2022.

Selection criteria: We included randomized controlled trials that studied adults and children with UC or CD. Eligible intervention arms used FMT, defined as the delivery of healthy donor stool containing gut microbiota to a recipient's GI tract, to treat UC or CD.

Data collection and analysis: Two review authors independently screened studies for inclusion. Our primary outcomes were: 1. induction of clinical remission, 2. maintenance of clinical remission, and 3. serious adverse events. Our secondary outcomes were: 4. any adverse events, 5. endoscopic remission, 6. quality of life, 7. clinical response, 8. endoscopic response, 9. withdrawals, 10. inflammatory markers, and 11. microbiome outcomes. We used the GRADE approach to assess the certainty of evidence.

Main results: We included 12 studies with 550 participants. Three studies were conducted in Australia; two in Canada; and one in each of the following: China, the Czech Republic, France, India, the Netherlands, and the USA. One study was conducted in both Israel and Italy. FMT was administered in the form of capsules or suspensions and delivered by mouth, nasoduodenal tube, enema, or colonoscopy. One study delivered FMT by both oral capsules and colonoscopy. Six studies were at overall low risk of bias, while the others had either unclear or high risk of bias. Ten studies with 468 participants, of which nine studies focused on adults and one focused on children, reported induction of clinical remission in people with UC at longest follow-up (range 6 to 12 weeks) and showed that FMT may increase rates of induction of clinical remission in UC compared to control (risk ratio (RR) 1.79, 95% confidence interval (CI) 1.13 to 2.84; low-certainty evidence). Five studies showed that FMT may increase rates of induction of endoscopic remission in UC at longest follow-up (range 8 to 12 weeks); however, the CIs around the summary estimate were wide and included a possible null effect (RR 1.45, 95% CI 0.64 to 3.29; low-certainty evidence). Nine studies with 417 participants showed that FMT may result in little to no difference in rates of any adverse events (RR 0.99, 95% CI 0.85 to 1.16; low-certainty evidence). The evidence was very uncertain about the risk of serious adverse events (RR 1.77, 95% CI 0.88 to 3.55; very low-certainty evidence) and improvement in quality of life (mean difference (MD) 15.34, 95% CI -3.84 to 34.52; very low-certainty evidence) when FMT was used to induce remission in UC. Two studies, of which one also contributed data for induction of remission in active UC, assessed maintenance of remission in people with controlled UC at longest follow-up (range 48 to 56 weeks). The evidence was very uncertain about the use of FMT for maintenance of clinical remission (RR 2.97, 95% CI 0.26 to 34.42; very low-certainty evidence) and endoscopic remission (RR 3.28, 95% CI 0.73 to 14.74; very low-certainty evidence). The evidence was also very uncertain about the risk of serious adverse events, risk of any adverse events, and improvement in quality of life when FMT was used to maintain remission in UC. None of the included studies assessed use of FMT for induction of remission in people with CD. One study with 21 participants reported data on FMT for maintenance of remission in people with CD. The evidence was very uncertain about the use of FMT for maintenance of clinical remission in CD at 24 weeks (RR 1.21, 95% CI 0.36 to 4.14; very low-certainty evidence). The evidence was also very uncertain about the risk of serious or any adverse events when FMT was used to maintain remission in CD. None of the studies reported data on use of FMT for maintenance of endoscopic remission or improvement in quality of life in people with CD.

Authors' conclusions: FMT may increase the proportion of people with active UC who achieve clinical and endoscopic remission. The evidence was very uncertain about whether use of FMT in people with active UC impacted the risk of serious adverse events or improvement in quality of life. The evidence was also very uncertain about the use of FMT for maintenance of remission in people with UC, as well as induction and maintenance of remission in people with CD, and no conclusive statements could be made in this regard. Further studies are needed to address the beneficial effects and safety profile of FMT in adults and children with active UC and CD, as well as its potential to promote longer-term maintenance of remission in UC and CD.

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Conflict of interest statement

AI: none.

NP: none.

MZ: none.

NZM: none.

ETS: none.

OG: none.

SA: none.

MN: none.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 Fecal microbiota transplantation (FMT) versus control for treatment of inflammatory bowel disease, outcome: 1.1 Induction of clinical remission in ulcerative colitis at longest follow‐up.
4
4
Funnel plot: FMT for induction of clinical remission for UC. The graph appears symmetrical.
5
5
Forest plot of comparison: 1 Fecal microbiota transplantation versus control for participants with ulcerative colitis, outcome: 1.8 Serious adverse events.
6
6
Funnel plot: serious adverse events for use of FMT for induction of remission in UC. The graph appears symmetrical.
1.1
1.1. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 1: Induction of clinical remission in UC at longest follow‐up
1.2
1.2. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 2: Induction of clinical remission in UC at 8 weeks
1.3
1.3. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 3: Induction of clinical remission in UC at 12 weeks
1.4
1.4. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 4: Induction of clinical remission in UC at longest follow‐up: subgroup analysis by route of administration
1.5
1.5. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 5: Induction of clinical remission in UC at longest follow‐up: subgroup analysis by type of donor
1.6
1.6. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 6: Induction of clinical remission in UC at longest follow‐up: subgroup analysis by age
1.7
1.7. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 7: Induction of clinical remission in UC at longest follow‐up: subgroup analysis by frequency of FMT
1.8
1.8. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 8: Induction of clinical remission in UC at longest follow‐up: sensitivity analysis using fixed‐effect model
1.9
1.9. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 9: Induction of clinical remission in UC at longest follow‐up: sensitivity analysis for available cases
1.10
1.10. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 10: Induction of clinical remission in UC at longest follow‐up: composite of clinical score and endoscopic score
1.11
1.11. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 11: Serious adverse events for induction of remission in UC
1.12
1.12. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 12: Serious adverse events for induction of remission in UC: subgroup analysis by route of administration
1.13
1.13. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 13: Serious adverse events for induction of remission in UC: subgroup analysis by type of donor
1.14
1.14. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 14: Serious adverse events for induction of remission in UC: subgroup analysis by age
1.15
1.15. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 15: Serious adverse events for induction of remission in UC: sensitivity analysis using fixed‐effect model
1.16
1.16. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 16: Serious adverse events for induction of remission in UC: sensitivity analysis for available cases
1.17
1.17. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 17: Any adverse events for induction of remission in UC
1.18
1.18. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 18: Induction of endoscopic remission in UC at longest follow‐up
1.19
1.19. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 19: Quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ]) scores at longest follow‐up for induction of remission in UC
1.20
1.20. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 20: Quality of life (IBDQ) scores at longest follow‐up for induction of remission in UC: sensitivity analysis without Haifer 2022
1.21
1.21. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 21: Induction of clinical response in UC at longest follow‐up
1.22
1.22. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 22: Induction of endoscopic response in UC at longest follow‐up
1.23
1.23. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 23: Withdrawals in studies on induction of remission in UC
1.24
1.24. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 24: Erythrocyte sedimentation rate (ESR) at longest follow‐up for induction of remission in UC (mm/hour)
1.25
1.25. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 25: ESR at longest follow‐up for induction of remission in UC: sensitivity analysis without Moayyedi 2015 (mm/hour)
1.26
1.26. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 26: C‐reactive protein (CRP) at longest follow‐up for induction of remission in UC (mg/L)
1.27
1.27. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 27: CRP at longest follow‐up for induction of remission in UC: sensitivity analysis without Moayyedi 2015 (mg/L)
1.28
1.28. Analysis
Comparison 1: Fecal microbiota transplantation (FMT) versus control for induction of remission in ulcerative colitis (UC), Outcome 28: Fecal calprotectin at longest follow‐up for induction of remission in UC (μg/mg)
2.1
2.1. Analysis
Comparison 2: Fecal microbiota transplantation (FMT) versus control for maintenance of remission in ulcerative colitis (UC), Outcome 1: Maintenance of clinical remission in UC
2.2
2.2. Analysis
Comparison 2: Fecal microbiota transplantation (FMT) versus control for maintenance of remission in ulcerative colitis (UC), Outcome 2: Maintenance of clinical remission in UC: sensitivity analysis using fixed‐effect model
2.3
2.3. Analysis
Comparison 2: Fecal microbiota transplantation (FMT) versus control for maintenance of remission in ulcerative colitis (UC), Outcome 3: Maintenance of clinical remission in UC: sensitivity analysis for available cases
2.4
2.4. Analysis
Comparison 2: Fecal microbiota transplantation (FMT) versus control for maintenance of remission in ulcerative colitis (UC), Outcome 4: Serious adverse events for maintenance of remission in UC
2.5
2.5. Analysis
Comparison 2: Fecal microbiota transplantation (FMT) versus control for maintenance of remission in ulcerative colitis (UC), Outcome 5: Any adverse events for maintenance of remission in UC
2.6
2.6. Analysis
Comparison 2: Fecal microbiota transplantation (FMT) versus control for maintenance of remission in ulcerative colitis (UC), Outcome 6: Maintenance of endoscopic remission in UC
2.7
2.7. Analysis
Comparison 2: Fecal microbiota transplantation (FMT) versus control for maintenance of remission in ulcerative colitis (UC), Outcome 7: Withdrawals in studies on maintenance of remission in UC
2.8
2.8. Analysis
Comparison 2: Fecal microbiota transplantation (FMT) versus control for maintenance of remission in ulcerative colitis (UC), Outcome 8: Erythrocyte sedimentation rate (ESR) at longest follow‐up for maintenance of remission in UC (mm/hour)
2.9
2.9. Analysis
Comparison 2: Fecal microbiota transplantation (FMT) versus control for maintenance of remission in ulcerative colitis (UC), Outcome 9: C‐reactive protein (CRP) at longest follow‐up for maintenance of remission in UC (mg/L)
4.1
4.1. Analysis
Comparison 4: Fecal microbiota transplantation (FMT) versus control for maintenance of remission in Crohn's disease (CD), Outcome 1: Maintenance of clinical remission in CD
4.2
4.2. Analysis
Comparison 4: Fecal microbiota transplantation (FMT) versus control for maintenance of remission in Crohn's disease (CD), Outcome 2: Withdrawals in studies on maintenance of remission in CD
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Paramsothy 2017 {published data only}
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Rossen 2015 {published data only}
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    1. Rossen NG, Fuentes S, Spek MJ, Tijssen JG, Hartman JH, Duflou A, et al. Findings from a randomized controlled trial of fecal transplantation for patients with ulcerative colitis. Gastroenterology 2015;149(1):110-8. [PMID: ] - PubMed
    1. Thiel IA, Rahman S, Hakvoort TB, Davids M, Verseijden C, Hamersveld PH, et al. Fecal filobasidium is associated with clinical remission and endoscopic response following fecal microbiota transplantation in mild-to-moderate ulcerative colitis. Microorganisms 2022;10(4):737. - PMC - PubMed
Sarbagili Shabat 2022 {unpublished data only}
    1. NCT02734589. Fecal transplantation using a diet for donor and recipient in refractory colitis. clinicaltrials.gov/ct2/show/NCT02734589 (first received 12 April 2016).
    1. Sarbagili Shabat C, Scaldaferri F, Zittan E, Hirsch A, Mentella MC, Musca T, et al. Use of faecal transplantation with a novel diet for mild to moderate active ulcerative colitis: the craft uc randomised controlled trial. Journal of Crohn's and Colitis 2022;16(3):369-78. [PMID: ] - PMC - PubMed
Sokol 2020 {published data only}
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Sood 2019a {published data only (unpublished sought but not used)}
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References to studies excluded from this review

Adler 2019 {published data only}
    1. Adler E, Tabaa A, Kassam Z, Zydek M, Terdiman J, El-Nachef N. Capsule-delivered fecal microbiota transplant is safe and well tolerated in patients with ulcerative colitis. Digestive Diseases and Sciences 2019;64(9):2452-4. - PubMed
Allegretti 2016 {published data only}
    1. Allegretti JR, Kassam Z, Smith M, Korzenik JR, Chan WW. Irregular bowel movements following fecal microbiota transplantation (FMT) are associated with pre-existing irritable bowel syndrome but not FMT-related factors. Gastroenterology 2016;150(4):S742.
Borody 2003 {published data only}
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Chen 2018 {published data only}
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Chen 2020 {published data only}
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Chin 2017 {published data only}
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Ding 2019 {published data only}
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El‐Nachef 2020 {published data only}
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Fang 2017 {published data only}
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Fischer 2016 {published data only}
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Gionchetti 2000 {published data only}
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Hourigan 2015 {published data only}
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Ishikawa 2017a {published data only}
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Ishikawa 2017b {published data only}
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Ishikawa 2019 {published data only (unpublished sought but not used)}
    1. Ishikawa D, Sasaki T, Takahashi M, Okahara K, Ito S, Haga K, et al. Combination therapy of fresh fecal microbial transplantation and triple-antibiotic therapy for ulcerative colitis. American Journal of Gastroenterology 2019;114:S14.
Ishikawa 2022 {published data only}
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Karolewska‐Bochenek 2018 {published data only}
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Kedia 2022 {published data only}
    1. Kedia S, Virmani S, Vuyyuru SK, Kumar P, Kante B, Sahu P, et al. Combination of fecal microbiota transplantation and anti-inflammatory diet induces clinical and deep remission in patients with mild-moderate ulcerative colitis. Gastroenterology 2022;162(7):S-1391.
    1. Kedia S, Virmani S, Vuyyuru SK, Kumar P, Kante B, Sahu P, et al. Faecal microbiota transplantation with anti-inflammatory diet (FMT-AID) followed by anti-inflammatory diet alone is effective in inducing and maintaining remission over 1 year in mild to moderate ulcerative colitis: a randomised controlled trial. Gut 2022;71(12):2401-13. - PubMed
Kump 2018 {published data only}
    1. Kump P, Wurm P, Gröchenig HP, Wenzl H, Petritsch W, Halwachs B, et al. The taxonomic composition of the donor intestinal microbiota is a major factor influencing the efficacy of faecal microbiota transplantation in therapy refractory ulcerative colitis. Alimentary Pharmacology and Therapeutics 2018;47(1):67-77. - PMC - PubMed
Landy 2013 {published data only}
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Li 2020 {published data only}
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    1. Li Q, Zhang T, Ding X, Xiang L, Cui B, Buch H, et al. Enhancing patient adherence to fecal microbiota transplantation maintains the long-term clinical effects in ulcerative colitis. European Journal of Gastroenterology and Hepatology 2020;32(8):955-62. - PubMed
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Ma 2020 {published data only}
    1. Ma J, Hudak J, Akbari P, Papkoff J. A rationally selected, orally administered, live biotherapeutic confortium of commensial bacteria for the treatment of ulcerative colitis. Gastroenterology 2020;158(6):S-472-3.
Mahajan 2018 {published data only}
    1. Mahajan R, Midha V, Mehta V, Singh A, Khattar H, Gupta Y, et al. Efficacy of faecal microbiota therapy in patients with steroid dependent active ulcerative colitis. Gut 2018;67:A74.
Mandalia 2016 {published data only}
    1. Mandalia A, Ward A, Tauxe W, Kraft CS, Dhere T. Fecal transplant is as effective and safe in immunocompromised as non-immunocompromised patients for Clostridium difficile. International Journal of Colorectal Disease 2016;31(5):1059-60. - PMC - PubMed
Michail 2018 {published data only}
    1. Michail S. Fecal microbial transplant in children with ulcerative colitis: a randomized, double-blinded, placebo-controlled pilot study: retracted. Journal of Pediatric Gastroenterology and Nutrition 2018;10.1097/MPG.0000000000001772:Study retracted. [DOI: 10.1097/MPG.0000000000001772] - DOI - PubMed
    1. NCT02291523. The effect of therapeutic fecal transplant on the gut microbiome in children with ulcerative colitis (FMT_UC). www.clinicaltrials.gov/ct2/show/NCT02291523 (first received 14 November 2014).
Mintz 2016 {published data only}
    1. Mintz M, Monzur F, Chowdhury T, Rowehl L, Grewal S, Li E, et al. Comparing fecal microbial transplant outcomes in patients with recurrent Clostridium difficile or ulcerative colitis. Inflammatory Bowel Diseases 2016;22(Suppl 1):S31.
NCT04436874 {published data only}
    1. NCT04436874. Fecal microbiota transplantation in the treatment of inflammatory bowel disease (FMT-IBD). clinicaltrials.gov/ct2/show/NCT04436874 (first received 18 June 2020).
NCT05202990 {published data only}
    1. NCT05202990. Oral fecal microbiota transplantation in pediatric ulcerative colitis (T-FORE). clinicaltrials.gov/ct2/show/NCT05202990 (first received 24 January 2022).
Okahara 2020 {published data only}
    1. Okahara K, Ishikawa D, Nomura K, Ito S, Haga K, Takahashi M, et al. Matching between donors and ulcerative colitis patients is important for long-term maintenance after fecal microbiota transplantation. Journal of Clinical Medicine 2020;9(6):1650. - PMC - PubMed
Osaki 2021 {published data only}
    1. Osaki H, Jodai Y, Koyama K, Omori T, Horiguchi N, Kamano T, et al. Clinical response and changes in the fecal microbiota and metabolite levels after fecal microbiota transplantation in patients with inflammatory bowel disease and recurrent Clostridioides difficile infection. Fujita Medical Journal 2021;7(3):87-98. - PMC - PubMed
Quraishi 2019 {published data only}
    1. Quraishi MN, Yalchin M, Blackwell C, Segal J, Sharma N, Hawkey P, et al. STOP-Colitis pilot trial protocol: a prospective, open-label, randomised pilot study to assess two possible routes of faecal microbiota transplant delivery in patients with ulcerative colitis. BMJ Open 2019;9(11):e030659. - PMC - PubMed
Quraishi 2022 {published data only}
    1. Quraishi N, Quince C, Hewitt C, Beggs A, Gerasimidis K, Sharma N, et al. Novel interactions between bacterial strains and mucosal immune profiles after FMT for UC: STOP-colitis results. Gut 2022;71:A28.
Rainer 2018 {published data only}
    1. Rainer F, Blesl A, Petritsch W, Wenzl HH, Baumann-Durchschein F, Posch A, et al. Frozen donor stool for fecal microbiota transplantation is as effective as fresh stool in inducing response and remission in active ulcerative colitis. United European Gastroenterology Journal 2018;6(Suppl 8):A69-70.
Silber 2022 {published data only}
    1. Silber J, Norman J, Kanno T, Crossette E, Szabady R, Menon R, et al. Randomized, double-blind, placebo (pbo)-controlled, single- and multiple-dose phase 1 study of VE202, a defined bacterial consortium for treatment of IBD: safety and colonization dynamics of a novel live biotherapeutic product (LBP) in healthy adults. Gastroenterology 2022;162(3):S65-6.
Smith 2022 {published data only}
    1. NCT03006809. Optimal fecal microbiota transplant dosing for mild to moderate ulcerative colitis. clinicaltrials.gov/ct2/show/NCT03006809 (first received 30 December 2016).
    1. Smith BJ, Piceno Y, Zydek M, Zhang B, Syriani LA, Terdiman JP, et al. Strain-resolved analysis in a randomized trial of antibiotic pretreatment and maintenance dose delivery mode with fecal microbiota transplant for ulcerative colitis. Scientific Reports 2022;12(1):5517. - PMC - PubMed
Sood 2019b {published data only}
    1. Sood A, Mahajan R, Juyal G, Midha V, Grewal CS, Mehta V, et al. Efficacy of fecal microbiota therapy in steroid dependent ulcerative colitis: a real world intention-to-treat analysis. Intestinal Research 2019;17(1):78-86. - PMC - PubMed
Steube 2019 {published data only}
    1. Steube A, Vital M, Grunert P, Pieper DH, Stallmach A. Long-term multidonor faecal microbiota transfer by oral capsules for active ulcerative colitis. Journal of Crohn's and Colitis 2019;13(11):1480-1. - PubMed
Tian 2019 {unpublished data only}
    1. NCT03016780. Fecal microbiota transplantation for ulcerative colitis (FMTFUC). clinicaltrials.gov/ct2/show/NCT03016780 (first received 11 January 2017).
    1. Tian Y, Zhou Y, Huang S, Li J, Zhao K, Li X, et al. Fecal microbiota transplantation for ulcerative colitis: a prospective clinical study. BMC Gastroenterology 2019;19(1):116. - PMC - PubMed
UMIN000025846 {published data only}
    1. UMIN000025846. A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease. center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_his_list.cgi?recptno=R000029717 (first received 1 February 2017).
UMIN000026485 {published data only}
    1. UMIN000026485. Research on the efficacy of fecal microbiota transplantation and microbiota in Japanese children with ulcerative colitis. center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030424 (first received 9 March 2017).
UMIN000041968 {published data only}
    1. UMIN000041968. Single center randomized study: alginate combined fecal microbiota transplantation for ulcerative colitis. center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047906 (first received 1 October 2020).
Wei 2016 {published data only}
    1. Wei Y, Gong J, Zhu W, Tian H, Ding C, Gu L, et al. Pectin enhances the effect of fecal microbiota transplantation in ulcerative colitis by delaying the loss of diversity of gut flora. BMC Microbiology 2016;16(1):255. - PMC - PubMed
Xiang 2020 {published data only}
    1. NCT01793831. Standardized fecal microbiota transplantation for Crohn's disease [Efficacy and safety of standardized fecal microbiota transplantation for moderate to severe Crohn's disease]. clinicaltrials.gov/ct2/show/NCT01793831 (first received 18 February 2013).
    1. Xiang L, Ding X, Li Q, Wu X, Dai M, Long C, et al. Efficacy of faecal microbiota transplantation in Crohn's disease: a new target treatment? Microbial Biotechnology 2020;13(3):760-9. - PMC - PubMed
Yang 2020 {published data only}
    1. Yang Z, Bu C, Yuan W, Shen Z, Quan Y, Wu S, et al. Fecal microbiota transplant via endoscopic delivering through small intestine and colon: no difference for Crohn's disease. Digestive Diseases and Sciences 2020;65(1):150-7. - PubMed
    1. Yang Z, Wang X, Bu C. Fecal microbiota transplant for Crohn's disease: a prospective, randomized study in Chinese population. United European Gastroenterology Journal 2017;5(Suppl 5):A112-3.

References to studies awaiting assessment

Caenepeel 2022 {published data only}
    1. Caenepeel C, Deleu S, Arnauts K, Vázquez-Castellanos JF, Braekeleire S, Machiels K, et al. Standardized faecal microbiota transplantation with microbiome-guided donor selection in active UC patients: a randomized, placebo-controlled intervention study. Journal of Crohn's and Colitis 2022;16(Suppl 1):i003-4.
    1. Deleu S, Caenepeel C, Arnauts K, Vázquez-Castellanos JF, Braekeleire S, Machiels K, et al. Standardized fecal microbiota transplantation through microbiome-guided donor selection in active ulcerative colitis patients: a randomized, placebo-controlled intervention study. Gastroenterology 2022;162(7):S-95-6.
Jitsumura 2022 {published data only}
    1. Jitsumura M, Cunningham A, Hitchings MD, Wilkinson T, Kinross J, Row P, et al. Faecal microbiota transplant in ulcerative colitis (FMTUC) – a randomised clinical trial feasibility study. Journal of Crohn's and Colitis 2022;16(Suppl 1):i612-3.
    1. Jitsumura M, Cunningham AL, Hitchings MD, Islam S, Davies AP, Row PE, et al. Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study. BMJ Open 2018;8(10):e021987. - PMC - PubMed
NCT02272868 {published data only}
    1. NCT02272868. Fecal microbial transplant in pediatric Crohn's disease (FMTCD). clinicaltrials.gov/ct2/show/NCT02272868 (first received 23 October 2014).
Zhang 2019 {published data only}
    1. Zhang KQ, Jiang Q, Zhang HB. Effect of fecal microbiota transplantation on gastrointestinal function and intestinal flora in patients with ulcerative colitis. Shijie Huaren Xiaohua Zazhi 2019;27(1):68-72.

References to ongoing studies

CTRI/2021/03/032131 {published data only}
    1. CTRI/2021/03/032131. Stool transplant for treatment of colitis and Crohns disease. trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2021/03/032131 (first received 18 March 2021).
EUCTR 2019‐003816‐29 {published data only}
    1. EUCTR 2019-003816-29. Fecal microbiota transplantation in Crohn's disease as relay after anti-TNF withdrawal. www.clinicaltrialsregister.eu/ctr-search/trial/2019-003816-29/FR (first received 14 October 2019).
NCT01961492 {published data only}
    1. NCT01961492. Fecal microbiota transplantation in patients with ulcerative colitis. clinicaltrials.gov/ct2/show/NCT01961492 (first received 11 October 2013).
NCT02335281 {published data only}
    1. NCT02335281. Standardized fecal microbiota transplantation for inflammatory bowel disease (SFMT-IBD). clinicaltrials.gov/ct2/show/NCT02335281 (first received 9 January 2015).
NCT02998112 {published data only}
    1. NCT02998112. Fecal microbiota transplantation for ulcerative colitis through colonic transendoscopic enteral tubing. clinicaltrials.gov/ct2/show/NCT02998112 (first received 20 December 2016).
NCT03078803 {published data only}
    1. NCT03078803. Fecal transplant for Crohn's disease. clinicaltrials.gov/ct2/show/NCT03078803 (first received 13 March 2017).
NCT03110289 {published data only}
    1. NCT03110289. Restoration of the microbiome through superdonor selection (RESTORE-UC). clinicaltrials.gov/ct2/show/NCT03110289 (first received 12 April 2017).
NCT03273465 {published data only}
    1. NCT03273465. Fecal microbiota transplantation in ulcerative colitis. clinicaltrials.gov/ct2/show/NCT03273465 (first received 6 September 2017).
NCT03483246 {published data only}
    1. NCT03483246. Impact of fecal microbiota transplantation in ulcerative colitis (REBALANCE-UC). clinicaltrials.gov/ct2/show/NCT03483246 (first received 30 March 2018).
NCT03561532 {published data only}
    1. NCT03561532. Fecal transplantation in ulcerative colitis (FMT-CU). clinicaltrials.gov/ct2/show/NCT03561532 (first received 19 June 2018).
NCT03582969 {published data only}
    1. NCT03582969. Capsulized fecal microbiota transplantation in pediatric ulcerative colitis patients (FMT UC). clinicaltrials.gov/ct2/show/NCT03582969 (first received 11 July 2018).
NCT03716388 {published data only}
    1. NCT03716388. Fecal microbiota therapy vs 5-aminosalicylates for induction of remission in newly diagnosed mild-moderately active UC. clinicaltrials.gov/ct2/show/NCT03716388 (first received 23 October 2018).
NCT03804931 {published data only}
    1. NCT03804931. Fecal microbiota transplantation for ulcerative colitis. clinicaltrials.gov/ct2/show/NCT03804931 (first received 15 January 2019).
NCT03998488 {published data only}
    1. NCT03998488. Examining the efficacy of fecal microbiota transplantation (FMT) and dietary fiber in patients with ulcerative colitis (MINDFUL). clinicaltrials.gov/ct2/show/NCT03998488 (first received 26 June 2019).
NCT04034758 {published data only}
    1. NCT04034758. Safety and efficacy of heterologous FMT by SQIMC-md capsule in mild-moderate ulcerative colitis patients (SQIMC-md). clinicaltrials.gov/ct2/show/NCT04034758 (first received 26 July 2019).
NCT04202211 {published data only}
    1. NCT04202211 [FMT for remission of active ulcerative colitis in adults]. clinicaltrials.gov/ct2/show/NCT04202211 (first received 17 December 2019).
NCT04328922 {published data only}
    1. NCT04328922. Fecal microbial transplantation and vedolizumab treatment of Crohn's disease. clinicaltrials.gov/ct2/show/NCT04328922 (first received 1 April 2020).
NCT04373473 {published data only}
    1. NCT04373473. Evaluation of the safety and efficacy of lyophilized fecal microbiota transplantation administered orally for prevention of relapse or intestinal inflammation in adults with ulcerative colitis. clinicaltrials.gov/ct2/show/NCT04373473 (first received 4 May 2020).
NCT04434872 {published data only}
    1. NCT04434872. Fecal microbiota transplantation as a treatment for ulcerative colitis. clinicaltrials.gov/ct2/show/NCT04434872 (first received 17 June 2020).
NCT04521205 {published data only}
    1. NCT03426683. The effect of intestinal microbiota transplantation for inflammatory bowel diseases (IBD). clinicaltrials.gov/ct2/show/NCT03426683 (first received 8 February 2018).
    1. NCT04521205. A multicenter clinical trial: efficacy, safety of fecal microbiota transplantation for inflammatory bowel disease. clinicaltrials.gov/ct2/show/NCT04521205 (first received 20 August 2020).
NCT04637438 {published data only}
    1. NCT04637438. Fecal microbiota transplantation in postoperative Crohn's disease. clinicaltrials.gov/ct2/show/NCT04637438 (first received 19 November 2020).
NCT04924270 {published data only}
    1. NCT04924270. Safety and efficacy of faecal microbiota transplantation in treatment-naïve patients with newly diagnosed chronic inflammatory diseases (FRONT). clinicaltrials.gov/ct2/show/NCT04924270 (first received 11 June 2021).
NCT04970446 {published data only}
    1. NCT04970446. The MIRO II study: microbial restoration in inflammatory bowel diseases (MIRO II). clinicaltrials.gov/ct2/show/NCT04970446 (first received 21 July 2021).
NCT04997733 {published data only}
    1. NCT04997733. Fecal microbiota transplantation in Crohn's disease as relay after anti-TNF withdrawal (MIRACLE). clinicaltrials.gov/ct2/show/NCT04997733 (first received 10 August 2021).
NCT05030064 {published data only}
    1. NCT05030064. Clinical study on the fecal microbiota transplantation in the treatment of ulcerative colitis with depression. clinicaltrials.gov/ct2/show/NCT05030064 (first received 1 September 2021).
NCT05538026 {published data only}
    1. NCT05538026. Effectiveness of fecal microbiota transplantation as add-on therapy in mild-to-moderate ulcerative colitis. clinicaltrials.gov/ct2/show/NCT05538026 (first received 13 September 2022).
Pai 2019 {published data only}
    1. Pai N, Popov J, Hill L, Hartung E. Protocol for a double-blind, randomised, placebo-controlled pilot study for assessing the feasibility and efficacy of faecal microbiota transplant in a paediatric Crohn's disease population: PediCRaFT Trial. BMJ Open 2019;9(11):e030120. - PMC - PubMed
Stallmach 2022 {published data only}
    1. Stallmach A, Grunert P, Stallhofer J, Löffler B, Baier M, Rödel J, et al. Transfer of FRozen Encapsulated multi-donor Stool filtrate for active ulcerative Colitis (FRESCO): study protocol for a prospective, multicenter, double-blind, randomized, controlled trial. Trials 2022;23(1):173. - PMC - PubMed
UMIN000033127 {published data only}
    1. UMIN000033127. Multicenter randomized controlled trial to study the efficacy of multidonor fecal microbiota transplantation for Crohn's disease. center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037777 (first received 24 June 2018).

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