Fecal Microbiota Transplantation for the Treatment of Obesity
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/24/2018 |
| Start Date: | April 1, 2017 |
| End Date: | October 18, 2019 |
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.
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.
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
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-6389
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
Click here to add this to my saved trials
