Evidence map›Paper›PMID 25857665›Full record

Trial reportGastroenterology2015

Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial.

Paul Moayyedi, Michael G Surette, Peter T Kim, Josie Libertucci, Melanie Wolfe, Catherine Onischi, David Armstrong, John K Marshall, Zain Kassam, Walter Reinisch and 1 more

15 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 15 registered trials, which are not on this map. Cited by 813 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
813citing papers in PubMed, 16 pooled it
83.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01545908 phase2completednot on this map

A Randomized Controlled Trial of Fecal Biotherapy for the Induction of Remission in Active Ulcerative Colitis

TypeinterventionalSponsorHamilton Health Sciences CorporationRan2012 to 2014Enrolled130ConditionsUlcerative ColitisArmsFecal transplant, Placebo enema
NCT02487238 phase1completednot on this map

A Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease Unclassified

TypeinterventionalSponsorMcMaster Children's HospitalRan2015 to 2018Enrolled35ConditionsInflammatory Bowel Disease, Ulcerative ColitisArmsFecal Microbiota Enema, Normal Saline Enema
NCT02998112 phase4unknown statusnot on this mapstarted 2016, after this paper: background citation

Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

TypeinterventionalSponsorThe Second Hospital of Nanjing Medical UniversityRan2016 to 2017Enrolled188ConditionsUlcerative ColitisArmsfecal microbiota transplantation, Saline
NCT03127696 nacompletednot on this mapstarted 2017, after this paper: background citation

A Randomised Placebo-controlled Study of Fecal Microbiota Transplant (FMT) to Impact Body Weight and Glycemic Control in Obese Subjects With Type 2 Diabetes Mellitus

TypeinterventionalSponsorChinese University of Hong KongRan2017 to 2019Enrolled61ConditionsType2 Diabetes, Type 2 Diabetes Mellitus, ObeseArmsFecal Microbiota Transplantation, Lifestyle Modification Program, Sham
NCT03273465 phase2unknown statusnot on this mapstarted 2017, after this paper: background citation

Fecal Microbiota Transplantation in Newly Diagnosed Patients With Ulcerative Colitis - a Double Blind, Placebo-Controlled Trial

TypeinterventionalSponsorAssaf-Harofeh Medical CenterRan2017 to 2021Enrolled100ConditionsUlcerative ColitisArmsFecal transplantation
NCT03483246 phase3active not recruitingnot on this mapstarted 2018, after this paper: background citation

Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2018 to 2027Enrolled150ConditionsUlcerative ColitisArmsFecal Microbiota Transplantation (FMT), Sham-transplantation Placebo
NCT03582969 phase2unknown statusnot on this mapstarted 2018, after this paper: background citation

High Intensity, Multi-Donor, Oral Capsulized Fecal Microbiota Transplantation in Newly Diagnosed Pediatric Patients With Mild to Moderate Ulcerative Colitis - a Double Blind, Placebo-Controlled Trial

TypeinterventionalSponsorAssaf-Harofeh Medical CenterRan2018 to 2022Enrolled100ConditionsUlcerative ColitisArmsFecal transplantation, Placebo
NCT03789461 naunknown statusnot on this mapstarted 2018, after this paper: background citation

An Open-label Pilot Study of Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects

TypeinterventionalSponsorChinese University of Hong KongRan2018 to 2022Enrolled20ConditionsObesityArmsFecal Microbiota Transplantation
NCT03817125 phase1completednot on this mapstarted 2019, after this paper: background citation

A Multicenter Phase 1b Randomized, Placebo-controlled, Blinded Study to Evaluate the Safety, Tolerability and Efficacy of Microbiome Study Intervention Administration in Combination With Anti-PD-1 Therapy in Adult Patients With Unresectable or Metastatic Melanoma

TypeinterventionalSponsorParker Institute for Cancer ImmunotherapyRan2019 to 2022Enrolled14ConditionsMetastatic MelanomaArmsPlacebo for antibiotic, Vancomycin pretreatment, Nivolumab, Matching Placebo for SER-401, SER-401
NCT04014413 narecruitingnot on this mapstarted 2019, after this paper: background citation

Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study

TypeinterventionalSponsorChinese University of Hong KongRan2019 to 2030Enrolled450ConditionsCrohn Disease, Ulcerative Colitis, Celiac Disease, Irritable Bowel SyndromeArmsFecal Microbiota Transplantation
NCT04926103 narecruitingnot on this mapstarted 2022, after this paper: background citation

Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. the FUEL Study

TypeinterventionalSponsorHamilton Health Sciences CorporationRan2022 to 2029Enrolled200ConditionsUlcerative Colitis FlareArmsFecal Microbiota transplant (FMT)
NCT04997733 phase3recruitingnot on this mapstarted 2021, after this paper: background citation

Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2021 to 2029Enrolled150ConditionsCrohn DiseaseArmsFecal Microbiota Transplantation (FMT), Sham-transplantation (placebo)
NCT05669651 naunknown statusnot on this mapstarted 2022, after this paper: background citation

A Multicenter, Prospective, Randomized Controlled Study to Explore the Efficacy and Safety of Fecal Microbiota Transplantation With Different Bacterial Doses in the Treatment of Recurrent Hepatic Encephalopathy

TypeinterventionalSponsorHainv GaoRan2022 to 2025Enrolled100ConditionsHepatic EncephalopathyArmsFecal Microbiota Transplantation
NCT06845527 recruitingnot on this mapstarted 2025, after this paper: background citation

Characteristics and Outcomes of Outpatients Referred to an Gut Microbiota Clinic

Typeobservational_patient_registrySponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2025 to 2027Enrolled400ConditionsIntestinal DiseaseArmsMicrobiome testing and Cytokine profiling
NCT06992453 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Disentangling Microbiome Engraftment by Multi-omics of the Gut Ecosystem During Fecal Transplant

TypeinterventionalSponsorCatholic University of the Sacred HeartRan2026 to 2029Enrolled90ConditionsRecurrent C. Difficile (rCDI), Ulcerative Colitis (UC), Metabolic Syndrome (MetS)ArmsFecal microbiota transplantation (FMT)
3 · Its place in the literature

Who cites it

813 citing papers in PubMed, 16 syntheses or guidelines pooled it, 1,476 citations in OpenAlex.

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753 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 2 countries.

Paul MoayyediFarncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada. Electronic address: moayyep@mcmaster.ca.
Michael G SuretteFarncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Peter T KimDepartment of Mathematics and Statistics, University of Guelph, Guelph, Ontario, Canada; Department of Pathology and Molecular Medicine, St Joseph's Healthcare, McMaster University, Hamilton, Ontario, Canada.
Josie LibertucciFarncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Melanie WolfeFarncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Catherine OnischiDepartment of Pathology and Molecular Medicine, St Joseph's Healthcare, McMaster University, Hamilton, Ontario, Canada.
David ArmstrongFarncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
John K MarshallFarncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Zain KassamDepartment of Biological Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts.
Walter ReinischFarncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Christine H LeeDepartment of Pathology and Molecular Medicine, St Joseph's Healthcare, McMaster University, Hamilton, Ontario, Canada.
McMaster University · CAPopulation Health Research Institute · CAMassachusetts Institute of Technology · USSt. Joseph’s Healthcare Hamilton · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsUlcerative colitis (UC) is difficult to treat, and standard therapy does not always induce remission. Fecal microbiota transplantation (FMT) is an alternative approach that induced remission in small series of patients with active UC. We investigated its safety and efficacy in a placebo-controlled randomized trial.

methodsWe performed a parallel study of patients with active UC without infectious diarrhea. Participants were examined by flexible sigmoidoscopy when the study began and then were randomly assigned to groups that received FMT (50 mL, via enema, from healthy anonymous donors; n = 38) or placebo (50 mL water enema; n = 37) once weekly for 6 weeks. Patients, clinicians, and investigators were blinded to the groups. The primary outcome was remission of UC, defined as a Mayo score ≤2 with an endoscopic Mayo score of 0, at week 7. Patients provided stool samples when the study began and during each week of FMT for microbiome analysis. The trial was stopped early for futility by the Data Monitoring and Safety Committee, but all patients already enrolled in the trial were allowed to complete the study.

resultsSeventy patients completed the trial (3 dropped out from the placebo group and 2 from the FMT group). Nine patients who received FMT (24%) and 2 who received placebo (5%) were in remission at 7 weeks (a statistically significant difference in risk of 17%; 95% confidence interval, 2%-33%). There was no significant difference in adverse events between groups. Seven of the 9 patients in remission after FMT received fecal material from a single donor. Three of the 4 patients with UC ≤1 year entered remission, compared with 6 of 34 of those with UC >1 year (P = .04, Fisher's exact test). Stool from patients receiving FMT had greater microbial diversity, compared with baseline, than that of patients given the placebo (P = .02, Mann-Whitney U test).

conclusionsFMT induces remission in a significantly greater percentage of patients with active UC than placebo, with no difference in adverse events. Fecal donor and time of UC appear to affect outcomes. ClinicalTrials.gov Number: NCT01545908.

Indexed as

MicrobiotaAdultAgedBiological TherapyColitis, UlcerativeFecesFemaleHumansMaleMiddle AgedRemission InductionColonIBDMicrobeTreatment

Identifiers

PMID25857665
OpenAlexW2078754045

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

and 9 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.