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Fecal Microbiota Transplant for Obesity and Metabolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Elaine W. Yu, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02530385
First received: August 19, 2015
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
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 Intervention Phase
Obesity
Other: Placebo Capsules
Biological: FMT Capsules
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Insulin Resistance (HOMA-IR and hyperinsulinemic euglycemic clamp) [ Time Frame: 6 weeks ]
    Change in insulin sensitivity from baseline to 6 weeks will be measured via HOMA-IR and by hyperinsulinemic euglycemic clamp.


Secondary Outcome Measures:
  • Body weight (metabolic scale) [ Time Frame: 12 weeks ]
    Change in body weight from baseline to 12 weeks will be measured on a metabolic scale.

  • Body Composition (DXA) [ Time Frame: 12 weeks ]
    Changes in lean and fat mass from baseline to 12 weeks will be measured via dual-energy x-ray absorptiometry


Estimated Enrollment: 24
Study Start Date: June 2016
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02530385

Contacts
Contact: Petr Stastka, BS 617-643-7951 pstastka@partners.org
Contact: Jasmin Mahabamunuge, BA 617-724-8625 jmahabamunuge@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
Contact: Petr Stastka, BS       pstastka@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Responsible Party: Elaine W. Yu, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02530385     History of Changes
Other Study ID Numbers: 2015-P001632
Study First Received: August 19, 2015
Last Updated: September 12, 2016

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on March 28, 2017