Obesity
Conditions
Keywords
obesity, FMT
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.
Interventions
BIOLOGICALFecal Microbiota Transplantation
This is pre-screened fecal material that has been encapsulated
OTHERPlacebo
These are capsules that have no fecal material in them.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 14\. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Frequency | 6 months | Number of patients reporting adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| 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. | 11 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Treatment Arm | Placebo Arm | Total |
|---|---|---|---|
| Age, Continuous | 44.5 years | 43.3 years | 43.9 years |
| BMI | 41.1 Kg/m^2 | 40.4 Kg/m^2 | 40.8 Kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 11 Participants | 20 Participants |
| Region of Enrollment United States | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 11 / 11 | 11 / 11 |
| serious Total, serious adverse events | 1 / 11 | 0 / 11 |
Outcome results
Primary
Adverse Event Frequency
Number of patients reporting adverse events
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Arm | Adverse Event Frequency | Patients experiencing AEs | 11 Participants |
| Treatment Arm | Adverse Event Frequency | Patients who Experienced SAE | 1 Participants |
| Placebo Arm | Adverse Event Frequency | Patients experiencing AEs | 11 Participants |
| Placebo Arm | Adverse Event Frequency | Patients who Experienced SAE | 0 Participants |
Secondary
Assess Change of AUC of GLP-1 as a Therapeutic Biomarker for Clinical Response to Fecal Microbiota Transplantation From Baseline to Week 12
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
Population: Population analyzed includes all subjects except for the two subjects who withdrew mid study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | 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 |
| Placebo Arm | Assess Change of AUC of GLP-1 as a Therapeutic Biomarker for Clinical Response to Fecal Microbiota Transplantation From Baseline to Week 12 | 311.3 pg/ml x minutes | Standard Error 261 |