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Trial record 1 of 1 for:    NCT02530385
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Fecal Microbiota Transplant for Improvement of Metabolism (FMT-TRIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02530385
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Elaine W. Yu, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Obesity
Interventions Other: Placebo Capsules
Biological: FMT Capsules
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo FMT Capsules
Hide Arm/Group Description

Placebo capsules

Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin

Active FMT capsules

FMT Capsules: Capsules will be generated as per FDA-approved procedures

Period Title: Overall Study
Started 12 12
Completed 12 11
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title FMT Capsules Placebo Total
Hide Arm/Group Description

Active FMT capsules

FMT Capsules: Capsules will be generated as per FDA-approved procedures

Placebo capsules

Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
42.5  (8.4) 38.5  (8.8) 40.5  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
8
  66.7%
9
  75.0%
17
  70.8%
Male
4
  33.3%
3
  25.0%
7
  29.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Hispanic or Latino
2
  16.7%
1
   8.3%
3
  12.5%
Not Hispanic or Latino
10
  83.3%
11
  91.7%
21
  87.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   8.3%
1
   8.3%
2
   8.3%
White
11
  91.7%
11
  91.7%
22
  91.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp
Hide Description [Not Specified]
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo FMT Capsules
Hide Arm/Group Description:

Placebo capsules

Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin

Active FMT capsules

FMT Capsules: Capsules will be generated as per FDA-approved procedures

Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: percent change
-3  (32) 5  (12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, FMT Capsules
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR)
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo FMT Capsules
Hide Arm/Group Description:

Placebo capsules

Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin

Active FMT capsules

FMT Capsules: Capsules will be generated as per FDA-approved procedures

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: unitless
Baseline 3.5  (1.9) 3.5  (1.4)
12 weeks 4.8  (1.7) 4.7  (2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, FMT Capsules
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Body Weight (Metabolic Scale)
Hide Description Change in body weight from baseline to 12 weeks will be measured on a metabolic scale.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo FMT Capsules
Hide Arm/Group Description:

Placebo capsules

Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin

Active FMT capsules

FMT Capsules: Capsules will be generated as per FDA-approved procedures

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: kg
Baseline 111  (20) 110  (26)
12 weeks 111  (19) 111  (27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, FMT Capsules
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Lean Mass
Hide Description Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo FMT Capsules
Hide Arm/Group Description:

Placebo capsules

Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin

Active FMT capsules

FMT Capsules: Capsules will be generated as per FDA-approved procedures

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: kg
Baseline 58  (12) 60  (15)
12 week 58  (11) 61  (16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, FMT Capsules
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Fat Mass
Hide Description Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo FMT Capsules
Hide Arm/Group Description:

Placebo capsules

Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin

Active FMT capsules

FMT Capsules: Capsules will be generated as per FDA-approved procedures

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: kg
Baseline 53  (10) 49  (13)
12 weeks 52  (10) 50  (14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, FMT Capsules
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description Questionnaire administered at every study visit.
 
Arm/Group Title Placebo FMT Capsules
Hide Arm/Group Description

Placebo capsules

Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin

Active FMT capsules

FMT Capsules: Capsules will be generated as per FDA-approved procedures

All-Cause Mortality
Placebo FMT Capsules
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
Placebo FMT Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      0/12 (0.00%)    
Cardiac disorders     
Chest pain *  1/12 (8.33%)  1 0/12 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo FMT Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/12 (58.33%)      10/12 (83.33%)    
Gastrointestinal disorders     
Diarrhea   5/12 (41.67%)  10/12 (83.33%) 
Bloating/Abdominal Pain   5/12 (41.67%)  7/12 (58.33%) 
Nausea/Vomiting   6/12 (50.00%)  6/12 (50.00%) 
General disorders     
Fever   2/12 (16.67%)  1/12 (8.33%) 
Fatigue   3/12 (25.00%)  5/12 (41.67%) 
Headache   4/12 (33.33%)  5/12 (41.67%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Elaine Yu
Organization: Massachusetts General Hospital Endocrine Unit
Phone: 617-726-6723
EMail: ewyu@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Elaine W. Yu, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02530385    
Other Study ID Numbers: 2015-P001632
First Submitted: August 19, 2015
First Posted: August 21, 2015
Results First Submitted: June 27, 2019
Results First Posted: July 25, 2019
Last Update Posted: July 25, 2019