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Completed

NCT Number: NCT02530385

Fecal Microbiota Transplant for Improvement of Metabolism

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Capsules

Other

Placebo capsules contain powdered cocoa and gelatin

FMT capsules

Biological

Capsules will be generated as per FDA-approved procedures

Primary outcomes

  1. Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp

    Time frame: Baseline and 6 weeks

Secondary outcomes

  1. Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: Baseline and 12 weeks

  2. 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.

  3. Lean Mass

    Time frame: Baseline and 12 weeks

    Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry

  4. Fat Mass

    Time frame: Baseline and 12 weeks

    Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Placebo Controlled Study of Fecal Microbiota Transplant (FMT) to Impact Body Weight and Glycemic Control in Adults Using a Frozen Encapsulated Inoculum

Acronym: FMT-TRIM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2015
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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