Fecal Microbiota Transplant for Improvement of Metabolism

Phase 1

Completed

• Conditions: Obesity
• Interventions: Biological: FMT Capsules; Other: Placebo Capsules

• Registration Number: NCT02530385
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Multiple lines of evidence suggest that gut microbiota play an important role in regulating human metabolism. In this study, subjects will receive FMT capsules from lean metabolically healthy donors to study effects on body weight and insulin sensitivity. Subjects who participate will be randomized 1:1 to receive either active FMT capsules or placebo capsules. Subjects and providers will be blinded to treatment assignment. The study will last for 24 weeks. Subjects will be asked to come to MGH for a baseline visit at week 0, return for 6 weekly visits and come back at week 12. Major study outcomes include change in weight, insulin sensitivity, and body composition. Fecal samples will also be collected for intestinal microbiome analysis.

Study Timeline

• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-21
• Study Start: 2016-06
• Primary Completion: 2018-06-27
• Study Completion: 2018-06-27
• Results First Submitted: 2019-06-27
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-18
• Last Update Submitted: 2019-07-18
• Results First Posted: 2019-07-25
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• BMI ≥30 kg/m2
• Because of frequent study mandated visits, only subjects living within reasonable driving distance of Massachusetts General Hospital may be enrolled

Exclusion Criteria

• Pregnant women
• Use of diabetic medications or weight loss medications in the preceding 1 year
• Significant gastrointestinal disorders
• Significant food allergies
• Immunosuppressed patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT	FMT Capsules	Active FMT capsules
Placebo	Placebo Capsules	Placebo capsules

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp	Baseline and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Lean Mass	Baseline and 12 weeks	Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry
Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR)	Baseline and 12 weeks
Body Weight (Metabolic Scale)	Baseline and 12 weeks	Change in body weight from baseline to 12 weeks will be measured on a metabolic scale.
Fat Mass	Baseline and 12 weeks	Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States