Fecal Microbiota Transplantation for the Treatment of Obesity (FMT Obesity)

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 eligible for outpatient screening colonoscopy who are obese (Body Mass Index of 35-50 kg/m2) 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 FMT at the time of their screening colonoscopy followed by weekly maintenance oral capsules for 12 weeks. The placebo group will receive a placebo slurry at the time of their screening colonoscopy followed by weekly intake of oral placebo capsules for 12 weeks.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for the Treatment of Obesity
Estimated Enrollment: 20
Study Start Date: July 2016
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Arms:
- Active Comparator: Treatment Arm
- Placebo Comparator: Placebo Arm