Trial record 1 of 1 for:    NCT02530385
Previous Study | Return to List | Next Study

Fecal Microbiota Transplant for Obesity and Metabolism

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. Identifier: NCT02530385
Recruitment Status : Active, not recruiting
First Posted : August 21, 2015
Last Update Posted : July 30, 2018
Information provided by (Responsible Party):
Elaine W. Yu, Massachusetts General Hospital

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 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

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT02530385

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
Sponsors and Collaborators
Massachusetts General Hospital

Responsible Party: Elaine W. Yu, Assistant Professor, Massachusetts General Hospital Identifier: NCT02530385     History of Changes
Other Study ID Numbers: 2015-P001632
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

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