Fecal Microbiota Transplantation for the Treatment of Obesity

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT02741518

Run by

Brigham and Women's Hospital

People needed

22

Starts

2017-04-01

Expected to finish

2019-07-24

Last updated by the study team

2020-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Obesity defined as a BMI of 35kg/m2 or higher

You may not qualify if…

• Triglycerides > 500 mg/dL
• Use of antibiotics <8 weeks prior to participation
• Use of probiotics <4 weeks prior to participation
• Alcohol use of greater than 20g/daily or suspicion of alcohol abuse and dependence
• Substance abuse, current
• LFTS greater then 3x the ULN
• Cirrhosis.
• DM type 2 that is insulin dependent, treated with GLP1-agonists, or poorly controlled on oral medications (HbA1C > 10%)
• Use of any weight loss medication or participation in a weight loss study or program such as Weight Watchers
• 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
• Patients who are pregnant or breastfeeding
• Patients who are unable to give informed consent
• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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