Trial Outcomes & Findings for Fecal Microbiota Transplantation for the Treatment of Obesity (NCT NCT02741518)

NCT ID: NCT02741518

Last Updated: 2020-01-07

Results Overview

Number of patients reporting adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2020-01-07

Participant Flow

Participant milestones

Measure	Treatment Arm The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use Fecal Microbiota Transplantation: This is pre-screened fecal material that has been encapsulated	Placebo Arm The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8 Placebo: These are capsules that have no fecal material in them.
Overall Study STARTED	11	11
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Treatment Arm The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use Fecal Microbiota Transplantation: This is pre-screened fecal material that has been encapsulated	Placebo Arm The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8 Placebo: These are capsules that have no fecal material in them.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Fecal Microbiota Transplantation for the Treatment of Obesity

Baseline characteristics by cohort

Measure	Treatment Arm n=11 Participants The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use Fecal Microbiota Transplantation: This is pre-screened fecal material that has been encapsulated	Placebo Arm n=11 Participants The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8 Placebo: These are capsules that have no fecal material in them.	Total n=22 Participants Total of all reporting groups
Age, Continuous	44.5 years n=5 Participants	43.3 years n=7 Participants	43.9 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	11 Participants n=7 Participants	20 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	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
BMI	41.1 Kg/m^2 n=5 Participants	40.4 Kg/m^2 n=7 Participants	40.8 Kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Number of patients reporting adverse events

Outcome measures

Measure	Treatment Arm n=11 Participants The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use Fecal Microbiota Transplantation: This is pre-screened fecal material that has been encapsulated	Placebo Arm n=11 Participants The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8 Placebo: These are capsules that have no fecal material in them.
Adverse Event Frequency Patients experiencing AEs	11 Participants	11 Participants
Adverse Event Frequency Patients who Experienced SAE	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Population analyzed includes all subjects except for the two subjects who withdrew mid study

Fecal Microbiota Transplantation will lead to an increase in short chain fatty acids which will lead to an increase in the metabolic regulator GLP-1

Outcome measures

Measure	Treatment Arm n=10 Participants The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use Fecal Microbiota Transplantation: This is pre-screened fecal material that has been encapsulated	Placebo Arm n=10 Participants The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8 Placebo: These are capsules that have no fecal material in them.
Assess Change of AUC of GLP-1 as a Therapeutic Biomarker for Clinical Response to Fecal Microbiota Transplantation From Baseline to Week 12	509.6 pg/ml x minutes Standard Error 318.7	311.3 pg/ml x minutes Standard Error 261

Adverse Events

Treatment Arm

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Arm n=11 participants at risk The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use Fecal Microbiota Transplantation: This is pre-screened fecal material that has been encapsulated	Placebo Arm n=11 participants at risk The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8 Placebo: These are capsules that have no fecal material in them.
Gastrointestinal disorders ER Visit for Vomiting and Diarrhea	9.1% 1/11 • Number of events 1 • Adverse event data was collected over the course 6 months	0.00% 0/11 • Adverse event data was collected over the course 6 months

Other adverse events

Measure	Treatment Arm n=11 participants at risk The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use Fecal Microbiota Transplantation: This is pre-screened fecal material that has been encapsulated	Placebo Arm n=11 participants at risk The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8 Placebo: These are capsules that have no fecal material in them.
Gastrointestinal disorders Bloating	27.3% 3/11 • Number of events 4 • Adverse event data was collected over the course 6 months	0.00% 0/11 • Adverse event data was collected over the course 6 months
Gastrointestinal disorders Abdominal Pain	45.5% 5/11 • Number of events 6 • Adverse event data was collected over the course 6 months	63.6% 7/11 • Number of events 13 • Adverse event data was collected over the course 6 months
Gastrointestinal disorders Diarrhea	54.5% 6/11 • Number of events 9 • Adverse event data was collected over the course 6 months	54.5% 6/11 • Number of events 8 • Adverse event data was collected over the course 6 months
Gastrointestinal disorders Blood in stool	9.1% 1/11 • Number of events 1 • Adverse event data was collected over the course 6 months	0.00% 0/11 • Adverse event data was collected over the course 6 months
Gastrointestinal disorders Constipation	18.2% 2/11 • Number of events 2 • Adverse event data was collected over the course 6 months	0.00% 0/11 • Adverse event data was collected over the course 6 months
Gastrointestinal disorders Gas	9.1% 1/11 • Number of events 1 • Adverse event data was collected over the course 6 months	18.2% 2/11 • Number of events 2 • Adverse event data was collected over the course 6 months
Gastrointestinal disorders Heartburn	9.1% 1/11 • Number of events 2 • Adverse event data was collected over the course 6 months	9.1% 1/11 • Number of events 1 • Adverse event data was collected over the course 6 months
General disorders Insect Bite	9.1% 1/11 • Number of events 1 • Adverse event data was collected over the course 6 months	0.00% 0/11 • Adverse event data was collected over the course 6 months
General disorders Bruises	0.00% 0/11 • Adverse event data was collected over the course 6 months	9.1% 1/11 • Number of events 1 • Adverse event data was collected over the course 6 months
Nervous system disorders Headache	18.2% 2/11 • Number of events 3 • Adverse event data was collected over the course 6 months	9.1% 1/11 • Number of events 1 • Adverse event data was collected over the course 6 months
Respiratory, thoracic and mediastinal disorders Sinus infection	9.1% 1/11 • Number of events 1 • Adverse event data was collected over the course 6 months	0.00% 0/11 • Adverse event data was collected over the course 6 months
General disorders Fever	18.2% 2/11 • Number of events 3 • Adverse event data was collected over the course 6 months	18.2% 2/11 • Number of events 2 • Adverse event data was collected over the course 6 months
General disorders Nausea	27.3% 3/11 • Number of events 6 • Adverse event data was collected over the course 6 months	9.1% 1/11 • Number of events 1 • Adverse event data was collected over the course 6 months
General disorders Vomiting	9.1% 1/11 • Number of events 2 • Adverse event data was collected over the course 6 months	0.00% 0/11 • Adverse event data was collected over the course 6 months
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/11 • Adverse event data was collected over the course 6 months	9.1% 1/11 • Number of events 1 • Adverse event data was collected over the course 6 months

Additional Information

Dr. Jessica Allegretti

Brigham and Women's Hospital

Phone: 617-732-5500

Email: jallegretti@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place