CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Fecal Microbiota Transplantation +1 morebiological
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/NCT02741518
NCT02741518Phase 2Completed

Fecal Microbiota Transplantation for the Treatment of Obesity

Brigham and Women's Hospital·interventional·Posted Apr 18, 2016·Updated Jan 7, 2020

In Brief

A Phase 2 clinical trial evaluating Fecal Microbiota Transplantation and Placebo for Obesity. Completed, enrolled 22 participants across 1 site.

Detailed Summary

This is a randomized controlled pilot study to assess the microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or higher) after providing written informed consent. The study participants will be randomized 1:1 to either the treatment arm or the placebo arm. The treatment arm will receive an induction FMT with capsules followed by a monthly maintenance dose of oral capsules for 12 weeks total. The placebo group will receive a placebo capsules for induction followed by monthly intake of oral placebo capsules for 12 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 18, 2016
Enrollment StartApr 1, 2017
Primary CompletionOct 18, 2018
Study CompletionJul 24, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.2 years ago

Interventions

Fecal Microbiota Transplantationbiological

This is pre-screened fecal material that has been encapsulated

Placeboother

These are capsules that have no fecal material in them.