Fecal Microbiota Transplant for Improvement of Metabolism
FMT-TRIM
Placebo Controlled Study of Fecal Microbiota Transplant (FMT) to Impact Body Weight and Glycemic Control in Adults Using a Frozen Encapsulated Inoculum
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 obesity
Started Jun 2016
Typical duration for phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2015
CompletedFirst Posted
Study publicly available on registry
August 21, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2018
CompletedResults Posted
Study results publicly available
July 25, 2019
CompletedJuly 25, 2019
July 1, 2019
2.1 years
August 19, 2015
June 27, 2019
July 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp
Baseline and 6 weeks
Secondary Outcomes (4)
Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR)
Baseline and 12 weeks
Body Weight (Metabolic Scale)
Baseline and 12 weeks
Lean Mass
Baseline and 12 weeks
Fat Mass
Baseline and 12 weeks
Study Arms (2)
FMT
EXPERIMENTALActive FMT capsules
Placebo
PLACEBO COMPARATORPlacebo capsules
Interventions
Eligibility Criteria
You may qualify if:
- BMI ≥30 kg/m2
- Because of frequent study mandated visits, only subjects living within reasonable driving distance of Massachusetts General Hospital may be enrolled
You may not qualify if:
- Pregnant women
- Use of diabetic medications or weight loss medications in the preceding 1 year
- Significant gastrointestinal disorders
- Significant food allergies
- Immunosuppressed patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Yu EW, Gao L, Stastka P, Cheney MC, Mahabamunuge J, Torres Soto M, Ford CB, Bryant JA, Henn MR, Hohmann EL. Fecal microbiota transplantation for the improvement of metabolism in obesity: The FMT-TRIM double-blind placebo-controlled pilot trial. PLoS Med. 2020 Mar 9;17(3):e1003051. doi: 10.1371/journal.pmed.1003051. eCollection 2020 Mar.
PMID: 32150549DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Elaine Yu
- Organization
- Massachusetts General Hospital Endocrine Unit
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 19, 2015
First Posted
August 21, 2015
Study Start
June 1, 2016
Primary Completion
June 27, 2018
Study Completion
June 27, 2018
Last Updated
July 25, 2019
Results First Posted
July 25, 2019
Record last verified: 2019-07