Fecal Microbiota Transplant for Improvement of Metabolism

Massachusetts General Hospital24 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

Placebo CapsulesOTHER

Placebo capsules contain powdered cocoa and gelatin

FMT CapsulesBIOLOGICAL

Capsules will be generated as per FDA-approved procedures

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp

Time frame: Baseline and 6 weeks

Secondary Outcomes

Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR)

Time frame: Baseline and 12 weeks

Body Weight (Metabolic Scale)

Change in body weight from baseline to 12 weeks will be measured on a metabolic scale.

Time frame: Baseline and 12 weeks

Lean Mass

Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry

Time frame: Baseline and 12 weeks

Fat Mass

Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry

Time frame: Baseline and 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.