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Fecal Microbiota Transplant for Obesity and Metabolism

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ClinicalTrials.gov Identifier: NCT02530385
Recruitment Status : Recruiting
First Posted : August 21, 2015
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :
  1. 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 :
  1. Body weight (metabolic scale) [ Time Frame: 12 weeks ]
    Change in body weight from baseline to 12 weeks will be measured on a metabolic scale.

  2. 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


Eligibility Criteria

Information from the National Library of Medicine

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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

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


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
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017

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