CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Fecal filtrate from 150 g stool from healthy lean donors +1 morebiological
Likely dose
Fecal filtrate from 150 g stool from healthy lean donorsfrom 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/NCT02970877
NCT02970877Phase 2Completed

Fecal Microbiota Transplant From Healthy Lean Donors to Morbidly Obese Individuals: Effect on Insulin Resistance and Other Obesity-related Parameters. A Randomized Controlled Trial.

Johane Allard·interventional·Posted Nov 22, 2016·Updated Apr 24, 2025

In Brief

A Phase 2 clinical trial evaluating Fecal filtrate from 150 g stool from healthy lean donors and Fecal filtrate from 150 g of the recipient's own stool for Obesity, Morbid and Insulin Resistance. Completed, enrolled 29 participants across 1 site.

Detailed Summary

More and more people in Canada and around the world are severely (morbidly) obese, and this is associated with a high risk for poor blood sugar control (insulin resistance, IR) and diabetes. Weight loss is often very hard to achieve for morbidly obese patients. Bariatric surgery is a very effective treatment, but it has some risks and is not available to all patients. Therefore, alternative treatments are needed. The gut bacteria (intestinal microbiome) might play a role for the development of obesity and IR. Several studies in animals have shown that transferring stool from lean mice or humans into obese animals could lead to weight loss and improve IR. One human study has confirmed this. The investigators are therefore examining, whether transfer of stool from healthy lean people into morbidly obese patients with IR will improve blood sugar control, weight, and other obesity related parameters. This will be done in a randomized controlled trial. Effects on mental health and the bacterial in the mouth related to gum disease will also be assessed. If successful, fecal transfer could be a new alternative treatment approach for morbidly obese patients or those with IR who do not have access to or do not want to undergo bariatric surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 22, 2016
Enrollment StartMar 1, 2017
Primary CompletionJun 30, 2022
Study CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 9.6 years ago

Interventions

Fecal filtrate from 150 g stool from healthy lean donorsbiological

150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.

Fecal filtrate from 150 g of the recipient's own stoolbiological

150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.