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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02530385
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Elaine W. Yu, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Other: Placebo Capsules Biological: FMT Capsules Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Placebo Controlled Study of Fecal Microbiota Transplant (FMT) to Impact Body Weight and Glycemic Control in Adults Using a Frozen Encapsulated Inoculum
Study Start Date : June 2016
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : June 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Baseline and 12 weeks ]
  2. 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.

  3. Lean Mass [ Time Frame: Baseline and 12 weeks ]
    Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry

  4. Fat Mass [ Time Frame: Baseline and 12 weeks ]
    Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530385


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Elaine W. Yu, Massachusetts General Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] March 6, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Elaine W. Yu, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02530385    
Other Study ID Numbers: 2015-P001632
First Posted: August 21, 2015    Key Record Dates
Results First Posted: July 25, 2019
Last Update Posted: July 25, 2019
Last Verified: July 2019