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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT | Experimental | Active FMT capsules |
|
| Placebo | Placebo Comparator | Placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Capsules | Other | Placebo capsules contain powdered cocoa and gelatin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline and 12 weeks | |
| Body Weight (Metabolic Scale) | Change in body weight from baseline to 12 weeks will be measured on a metabolic scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32150549 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo capsules Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin |
| FG001 | FMT Capsules | Active FMT capsules FMT Capsules: Capsules will be generated as per FDA-approved procedures |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FMT Capsules | Active FMT capsules FMT Capsules: Capsules will be generated as per FDA-approved procedures |
| BG001 | Placebo | Placebo capsules Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp | 2 participants in the FMT Capsules group did not complete the 6 week study visit: 1 withdrew prior to the visit; 1 missed due to a scheduling issue. | Posted | Mean | Standard Deviation | percent change | Baseline and 6 weeks |
|
12 weeks
Questionnaire administered at every study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo capsules Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elaine Yu | Massachusetts General Hospital Endocrine Unit | 617-726-6723 | ewyu@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2019 | Jun 27, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| FMT Capsules |
| Biological |
Capsules will be generated as per FDA-approved procedures |
|
| Baseline and 12 weeks |
| Lean Mass | Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry | Baseline and 12 weeks |
| Fat Mass | Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry | Baseline and 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR) | Posted | Mean | Standard Deviation | unitless | Baseline and 12 weeks |
|
|
|
|
| Secondary | Body Weight (Metabolic Scale) | Change in body weight from baseline to 12 weeks will be measured on a metabolic scale. | Posted | Mean | Standard Deviation | kg | Baseline and 12 weeks |
|
|
|
|
| Secondary | Lean Mass | Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry | Posted | Mean | Standard Deviation | kg | Baseline and 12 weeks |
|
|
|
|
| Secondary | Fat Mass | Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry | Posted | Mean | Standard Deviation | kg | Baseline and 12 weeks |
|
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 7 |
| 12 |
| EG001 | FMT Capsules | Active FMT capsules FMT Capsules: Capsules will be generated as per FDA-approved procedures | 0 | 12 | 0 | 12 | 10 | 12 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Bloating/Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |