Fecal Microbiota Transplant for Improvement of Metabolism
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 25 - 60 |
| Updated: | 3/17/2019 |
| Start Date: | June 2016 |
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.
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.
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.
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
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