Phase 2
Completed N=24
Fecal Microbiota Transplant for Improvement of Metabolism
Source: ClinicalTrials.gov NCT02530385 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Jul 2019
Primary outcomePrimary: Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp — -3; 5 percent change — p=0.16
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp |
-3; 5 | 0.16 |
| SECONDARY Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR) |
3.5; 3.5; 4.8; 4.7 | 0.70 |
| SECONDARY Body Weight (Metabolic Scale) |
111; 110; 111; 111 | 0.93 |
| SECONDARY Lean Mass |
58; 60; 58; 61 | 0.90 |
| SECONDARY Fat Mass |
53; 49; 52; 50 | 0.32 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02530385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.