Fecal Microbiota Transplant for Improvement of Metabolism

Phase 1/2 Completed 24 enrolled Massachusetts General Hospital

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to study the impact of gut bacteria on weight. Fecal microbiota transplantation (FMT) transfers intestinal bacteria by a "stool transplant" from a healthy, lean person to a person with obesity.

Timeline

Start: 2016-06
Primary completion: 2018-06-27
Completion: 2018-06-27

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs FMT Capsules; p = 0.16; Wilcoxon (Mann-Whitney) NCT02530385 ↗

paper There were no statistically significant improvements in insulin sensitivity in the FMT group compared to the placebo group PMID 32150549 ↗

Publications

Yu EW, Gao L, Stastka P, Cheney MC, Mahabamunuge J, Torres Soto M, Ford CB, Bryant JA, Henn MR, Hohmann EL. Fecal microbiota transplantation for the improvement of metabolism in obesity: The FMT-TRIM double-blind placebo-controlled pilot trial. PLoS Med. 2020 Mar 9;17(3):e1003051. doi: 10.1371/journal.pmed.1003051. eCollection 2020 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FMT	Unknown	—	Oral