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Trial record 1 of 1 for:    NCT02530385
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Fecal Microbiota Transplant for Improvement of Metabolism (FMT-TRIM)

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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

Tracking Information
First Submitted Date  ICMJE August 19, 2015
First Posted Date  ICMJE August 21, 2015
Results First Submitted Date  ICMJE June 27, 2019
Results First Posted Date  ICMJE July 25, 2019
Last Update Posted Date July 25, 2019
Study Start Date  ICMJE June 2016
Actual Primary Completion Date June 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp [ Time Frame: Baseline and 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
Body weight (metabolic scale) [ Time Frame: 12 weeks ]
Change in body weight from baseline to 12 weeks will be measured on a metabolic scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: 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.
  • Lean Mass [ Time Frame: Baseline and 12 weeks ]
    Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry
  • Fat Mass [ Time Frame: Baseline and 12 weeks ]
    Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplant for Improvement of Metabolism
Official Title  ICMJE Placebo Controlled Study of Fecal Microbiota Transplant (FMT) to Impact Body Weight and Glycemic Control in Adults Using a Frozen Encapsulated Inoculum
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Other: Placebo Capsules
    Placebo capsules contain powdered cocoa and gelatin
  • Biological: FMT Capsules
    Capsules will be generated as per FDA-approved procedures
Study Arms  ICMJE
  • Experimental: FMT
    Active FMT capsules
    Intervention: Biological: FMT Capsules
  • Placebo Comparator: Placebo
    Placebo capsules
    Intervention: Other: Placebo Capsules
Publications * Yu EW, Gao L, Stastka P, Cheney MC, Mahabamunuge J, Torres Soto M, Ford CB, Bryant JA, Henn MR, Hohmann EL. Fecal microbiota transplantation for the improvement of metabolism in obesity: The FMT-TRIM double-blind placebo-controlled pilot trial. PLoS Med. 2020 Mar 9;17(3):e1003051. doi: 10.1371/journal.pmed.1003051. eCollection 2020 Mar.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2016)
24
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2015)
21
Actual Study Completion Date  ICMJE June 27, 2018
Actual Primary Completion Date June 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02530385
Other Study ID Numbers  ICMJE 2015-P001632
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elaine W. Yu, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date July 2019

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