Trial Outcomes & Findings for Fecal Microbiota Transplant for Improvement of Metabolism (NCT NCT02530385)
NCT ID: NCT02530385
Last Updated: 2019-07-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2019-07-25
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo capsules
Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin
|
FMT Capsules
Active FMT capsules
FMT Capsules: Capsules will be generated as per FDA-approved procedures
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo capsules
Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin
|
FMT Capsules
Active FMT capsules
FMT Capsules: Capsules will be generated as per FDA-approved procedures
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Fecal Microbiota Transplant for Improvement of Metabolism
Baseline characteristics by cohort
| Measure |
FMT Capsules
n=12 Participants
Active FMT capsules
FMT Capsules: Capsules will be generated as per FDA-approved procedures
|
Placebo
n=12 Participants
Placebo capsules
Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo capsules
Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin
|
FMT Capsules
n=10 Participants
Active FMT capsules
FMT Capsules: Capsules will be generated as per FDA-approved procedures
|
|---|---|---|
|
Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp
|
-3 percent change
Standard Deviation 32
|
5 percent change
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksOutcome measures
| Measure |
Placebo
n=12 Participants
Placebo capsules
Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin
|
FMT Capsules
n=12 Participants
Active FMT capsules
FMT Capsules: Capsules will be generated as per FDA-approved procedures
|
|---|---|---|
|
Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR)
Baseline
|
3.5 unitless
Standard Deviation 1.9
|
3.5 unitless
Standard Deviation 1.4
|
|
Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR)
12 weeks
|
4.8 unitless
Standard Deviation 1.7
|
4.7 unitless
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksChange in body weight from baseline to 12 weeks will be measured on a metabolic scale.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo capsules
Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin
|
FMT Capsules
n=12 Participants
Active FMT capsules
FMT Capsules: Capsules will be generated as per FDA-approved procedures
|
|---|---|---|
|
Body Weight (Metabolic Scale)
Baseline
|
111 kg
Standard Deviation 20
|
110 kg
Standard Deviation 26
|
|
Body Weight (Metabolic Scale)
12 weeks
|
111 kg
Standard Deviation 19
|
111 kg
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksChange in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo capsules
Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin
|
FMT Capsules
n=12 Participants
Active FMT capsules
FMT Capsules: Capsules will be generated as per FDA-approved procedures
|
|---|---|---|
|
Lean Mass
Baseline
|
58 kg
Standard Deviation 12
|
60 kg
Standard Deviation 15
|
|
Lean Mass
12 week
|
58 kg
Standard Deviation 11
|
61 kg
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksChange in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo capsules
Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin
|
FMT Capsules
n=12 Participants
Active FMT capsules
FMT Capsules: Capsules will be generated as per FDA-approved procedures
|
|---|---|---|
|
Fat Mass
Baseline
|
53 kg
Standard Deviation 10
|
49 kg
Standard Deviation 13
|
|
Fat Mass
12 weeks
|
52 kg
Standard Deviation 10
|
50 kg
Standard Deviation 14
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
FMT Capsules
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=12 participants at risk
Placebo capsules
Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin
|
FMT Capsules
n=12 participants at risk
Active FMT capsules
FMT Capsules: Capsules will be generated as per FDA-approved procedures
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
8.3%
1/12 • Number of events 1 • 12 weeks
Questionnaire administered at every study visit.
|
0.00%
0/12 • 12 weeks
Questionnaire administered at every study visit.
|
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Placebo capsules
Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin
|
FMT Capsules
n=12 participants at risk
Active FMT capsules
FMT Capsules: Capsules will be generated as per FDA-approved procedures
|
|---|---|---|
|
General disorders
Fever
|
16.7%
2/12 • 12 weeks
Questionnaire administered at every study visit.
|
8.3%
1/12 • 12 weeks
Questionnaire administered at every study visit.
|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
5/12 • 12 weeks
Questionnaire administered at every study visit.
|
83.3%
10/12 • 12 weeks
Questionnaire administered at every study visit.
|
|
Gastrointestinal disorders
Bloating/Abdominal Pain
|
41.7%
5/12 • 12 weeks
Questionnaire administered at every study visit.
|
58.3%
7/12 • 12 weeks
Questionnaire administered at every study visit.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
50.0%
6/12 • 12 weeks
Questionnaire administered at every study visit.
|
50.0%
6/12 • 12 weeks
Questionnaire administered at every study visit.
|
|
General disorders
Fatigue
|
25.0%
3/12 • 12 weeks
Questionnaire administered at every study visit.
|
41.7%
5/12 • 12 weeks
Questionnaire administered at every study visit.
|
|
General disorders
Headache
|
33.3%
4/12 • 12 weeks
Questionnaire administered at every study visit.
|
41.7%
5/12 • 12 weeks
Questionnaire administered at every study visit.
|
Additional Information
Dr. Elaine Yu
Massachusetts General Hospital Endocrine Unit
Phone: 617-726-6723
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place