FMT Obesity: Fecal Microbiota Transplantation for the Treatment of Obesity

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02741518
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.7
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This is a randomized controlled pilot study to assess the microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or higher) after providing written informed consent. The study participants will be randomized 1:1 to either the treatment arm or the placebo arm. The treatment arm will receive an induction FMT with capsules followed by a monthly maintenance dose of oral capsules for 12 weeks total. The placebo group will receive a placebo capsules for induction followed by monthly intake of oral placebo capsules for 12 weeks.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Biological: Fecal Microbiota Transplantation; Other: Placebo	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Fecal Microbiota Transplantation for the Treatment of Obesity
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Oct 18, 2018
• Actual Study Completion Date: Jul 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Biological: Fecal Microbiota Transplantation; This is pre-screened fecal material that has been encapsulated; Other Names: FMT
Placebo Comparator: 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	Other: Placebo; These are capsules that have no fecal material in them.

Outcome Measures

Primary Outcome Measures

1. Adverse Event Frequency [6 months]

   Number of patients reporting adverse events

Secondary Outcome Measures

1. Assess Change of AUC of GLP-1 as a Therapeutic Biomarker for Clinical Response to Fecal Microbiota Transplantation From Baseline to Week 12 [12 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 18 years or older

2. Obesity defined as a BMI of 35kg/m2 or higher

Exclusion Criteria:

1. Triglycerides > 500 mg/dL

2. Use of antibiotics <8 weeks prior to participation

3. Use of probiotics <4 weeks prior to participation

4. Alcohol use of greater than 20g/daily or suspicion of alcohol abuse and dependence

5. Substance abuse, current

6. LFTS greater then 3x the ULN

7. Cirrhosis.

8. DM type 2 that is insulin dependent, treated with GLP1-agonists, or poorly controlled on oral medications (HbA1C > 10%)

9. Use of any weight loss medication or participation in a weight loss study or program such as Weight Watchers

10. History of recent weight change (weight loss or weight gain in the two months preceding trial enrollment). This is defined as a gain or loss of 10 or more pounds in the preceding 2 months

11. Patients who are pregnant or breastfeeding

12. Patients who are unable to give informed consent

13. Patients who have previously undergone FMT 15. Patients who have a confirmed malignancy or cancer 16. Patients who are immunocompromised 17. Participation in a clinical trial in the preceding 30 days or simultaneously during this trial 18. Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, and ileocectomy 19. Other comorbidities including: systemic lupus, inflammatory bowel disease, or Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44 20. History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia 21. Any condition, based on clinical judgment that may make study participation unsafe 22. History of severe food allergies 23. Use of immune modulators including methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, Interleukin-10, or Interleukin-11 24.Treatment with infliximab, adalimumab, certolizumab, natalizumab, vedolizumab or thalidomide 25. Congenital or acquired immunodeficiencies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Christopher C Thompson, MD, MSC, Brigham and Women's Hospital
• Study Director: Jessica R Allegretti, MD, MPH, Brigham and Women's Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 16, 2018

More Information

Publications

None provided.

• Responsible Party: Christopher C. Thompson, MD, MSc, Attending Physician, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02741518
• Other Study ID Numbers: 2016P000075
• First Posted: Apr 18, 2016
• Last Update Posted: Jan 7, 2020
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Christopher C. Thompson, MD, MSc, Attending Physician, Brigham and Women's Hospital: obesity; FMT
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	Treatment Arm	Placebo Arm
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	11	11
COMPLETED	10	10
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Treatment Arm	Placebo Arm	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	11	11	22
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	44.5	43.3	43.9
Sex: Female, Male (Count of Participants)
Female	10 90.9%	10 90.9%	20 90.9%
Male	1 9.1%	1 9.1%	2 9.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 18.2%	0 0%	2 9.1%
White	9 81.8%	11 100%	20 90.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	11 100%	11 100%	22 100%
BMI (Kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [Kg/m^2]	41.1	40.4	40.8

Outcome Measures

1. Primary Outcome

Title	Adverse Event Frequency
Description	Number of patients reporting adverse events
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm	Placebo Arm
Arm/Group Description	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	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.
Measure Participants	11	11
Patients experiencing AEs	11 100%	11 100%
Patients who Experienced SAE	1 9.1%	0 0%

2. Secondary Outcome

Title	Assess Change of AUC of GLP-1 as a Therapeutic Biomarker for Clinical Response to Fecal Microbiota Transplantation From Baseline to Week 12
Description	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
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Treatment Arm	Placebo Arm
Arm/Group Description	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	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.
Measure Participants	10	10
Mean (Standard Error) [pg/ml x minutes]	509.6 (318.7)	311.3 (261)

Adverse Events

Time Frame	Adverse event data was collected over the course 6 months
Arm/Group Title	Treatment Arm		Placebo Arm
Arm/Group Description	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		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.
All Cause Mortality
	Treatment Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Serious Adverse Events
	Treatment Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)		0/11 (0%)
Gastrointestinal disorders
ER Visit for Vomiting and Diarrhea	1/11 (9.1%)	1	0/11 (0%)	0
Other (Not Including Serious) Adverse Events
	Treatment Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/11 (100%)		11/11 (100%)
Gastrointestinal disorders
Bloating	3/11 (27.3%)	4	0/11 (0%)	0
Abdominal Pain	5/11 (45.5%)	6	7/11 (63.6%)	13
Diarrhea	6/11 (54.5%)	9	6/11 (54.5%)	8
Blood in stool	1/11 (9.1%)	1	0/11 (0%)	0
Constipation	2/11 (18.2%)	2	0/11 (0%)	0
Gas	1/11 (9.1%)	1	2/11 (18.2%)	2
Heartburn	1/11 (9.1%)	2	1/11 (9.1%)	1
General disorders
Insect Bite	1/11 (9.1%)	1	0/11 (0%)	0
Bruises	0/11 (0%)	0	1/11 (9.1%)	1
Fever	2/11 (18.2%)	3	2/11 (18.2%)	2
Nausea	3/11 (27.3%)	6	1/11 (9.1%)	1
Vomiting	1/11 (9.1%)	2	0/11 (0%)	0
Musculoskeletal and connective tissue disorders
Back Pain	0/11 (0%)	0	1/11 (9.1%)	1
Nervous system disorders
Headache	2/11 (18.2%)	3	1/11 (9.1%)	1
Respiratory, thoracic and mediastinal disorders
Sinus infection	1/11 (9.1%)	1	0/11 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

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.