Fecal Microbiota Transplant for Improvement of Metabolism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Placebo Controlled Study of Fecal Microbiota Transplant (FMT) to Impact Body Weight and Glycemic Control in Adults Using a Frozen Encapsulated Inoculum

Conditions
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Obesity

Intervention / Treatment
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* Other: Placebo Capsules
* Biological: FMT Capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT<br>Active FMT capsules | Biological: FMT Capsules<br>* Capsules will be generated as per FDA-approved procedures<br>|
| Placebo Comparator: Placebo<br>Placebo capsules | Other: Placebo Capsules<br>* Placebo capsules contain powdered cocoa and gelatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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