Fecal Microbiota Transplant for Improvement of Metabolism (FMT-TRIM)

July 18, 2019 updated by: Elaine W. Yu, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp
Time Frame: Baseline and 6 weeks
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)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Body Weight (Metabolic Scale)
Time Frame: Baseline and 12 weeks
Change in body weight from baseline to 12 weeks will be measured on a metabolic scale.
Baseline and 12 weeks
Lean Mass
Time Frame: Baseline and 12 weeks
Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry
Baseline and 12 weeks
Fat Mass
Time Frame: Baseline and 12 weeks
Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

June 27, 2018

Study Completion (Actual)

June 27, 2018

Study Registration Dates

First Submitted

August 19, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

July 25, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-P001632

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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