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Phase 2 N=24 Randomized Double-blind Treatment

Fecal Microbiota Transplant for Improvement of Metabolism

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT02530385 ↗
Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Jul 2019
Primary outcome: Primary: 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

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Placebo Capsules (Other); FMT Capsules (Biological)
Age
Adult · 25+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-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

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.

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
View full record on ClinicalTrials.gov →

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.

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