Fecal Microbiota Transplant for Improvement of Metabolism

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-06-27

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.

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FMT

Active FMT capsules

Group Type EXPERIMENTAL

FMT Capsules

Intervention Type BIOLOGICAL

Capsules will be generated as per FDA-approved procedures

Placebo

Placebo capsules

Group Type PLACEBO_COMPARATOR

Placebo Capsules

Intervention Type OTHER

Placebo capsules contain powdered cocoa and gelatin

Interventions

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Placebo Capsules

Placebo capsules contain powdered cocoa and gelatin

Intervention Type OTHER

FMT Capsules

Capsules will be generated as per FDA-approved procedures

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No