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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):

August 19, 2015
August 21, 2015
May 22, 2017
June 2016
June 2018   (Final data collection date for primary outcome measure)
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.
Body weight (metabolic scale) [ Time Frame: 12 weeks ]
Change in body weight from baseline to 12 weeks will be measured on a metabolic scale
Complete list of historical versions of study NCT02530385 on ClinicalTrials.gov Archive Site
  • 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
  • Insulin Resistance (HOMA-IR and hyperinsulinemic euglycemic clamp) [ Time Frame: 12 weeks ]
    Change in insulin sensitivity from baseline to 12 weeks will be measured via HOMA-IR and by hyperinsulinemic euglycemic clamp (in a subset)
  • 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
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Fecal Microbiota Transplant for Obesity and Metabolism
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Obesity
  • Other: Placebo Capsules
    Placebo capsules contain powdered cocoa and gelatin
  • Biological: FMT Capsules
    Capsules will be generated as per FDA-approved procedures
  • Experimental: FMT
    Active FMT capsules
    Intervention: Biological: FMT Capsules
  • Placebo Comparator: Placebo
    Placebo capsules
    Intervention: Other: Placebo Capsules
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
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June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years to 60 Years   (Adult)
No
Contact: Petr Stastka, BS 617-643-7951 pstastka@partners.org
Contact: Jasmin Mahabamunuge, BA 617-724-8625 jmahabamunuge@partners.org
United States
 
 
NCT02530385
2015-P001632
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Elaine W. Yu, Massachusetts General Hospital
Massachusetts General Hospital
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Not Provided
Massachusetts General Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP