CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Fecal microbiota transplantation capsules +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02328547
NCT02328547Phase 2Completed
CompareCT.gov

Randomized, Double-blinded, Placebo-controlled Trial of Fecal Microbiota Transplantation (FMT) for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Montefiore Medical Center·interventional·Posted Dec 31, 2014·Updated Jul 2, 2019

In Brief

A Phase 2 clinical trial evaluating Fecal microbiota transplantation capsules and Placebo capsules for Irritable Bowel Syndrome. Completed, enrolled 48 participants across 3 sites.

Detailed Summary

The objectives of this study are (1) to determine the efficacy of fecal microbiota transplantation (FMT), given as oral capsules, compared with placebo for the treatment of refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact of FMT on the intestinal microbiome of patients with IBS-D; and (3) assess the safety, feasibility, and tolerability of FMT for patients with IBS-D.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 31, 2014
Enrollment StartMay 1, 2015
Primary CompletionOct 1, 2017
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.5 years ago

Interventions

Fecal microbiota transplantation capsulesdrug

Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA.

Placebo capsulesdrug

Placebo capsules prepared by OpenBiome, Medford, MA