drugset / Trial / NCT02741518

Fecal Microbiota Transplantation for the Treatment of Obesity

NCT02741518

Phase 1/2 Completed 22 enrolled Brigham and Women's Hospital
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2017-04-01
Primary completion
2018-10-18
Completion
2019-07-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ornidazole Other / unclassified 12 unknown Oral

Indications