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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Brigham and Women's Hospital
Information provided by (Responsible Party):
Christopher Thompson, Brigham and Women's Hospital Identifier:
First received: April 12, 2016
Last updated: February 12, 2017
Last verified: February 2017
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 Intervention Phase
Biological: Fecal Microbiota Transplantation
Other: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for the Treatment of Obesity

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Safety of fecal microbiota transplantation (FMT) as measured by number and nature of adverse events within 52 weeks of FMT [ Time Frame: 1 year ]
    Adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation patient administered a biologic product. It is an unintended sign, symptom, or disease temporally associated with the use of the investigational agent. Adverse events will be determined by a toxicity grading scale.

Estimated Enrollment: 20
Study Start Date: November 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Arm
The treatment arm will receive an FMT at the time of their screening colonoscopy followed by weekly maintenance oral capsules for 12 weeks. 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
Other Name: FMT
Placebo Comparator: Placebo Arm
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.
Other: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02741518

Contact: Jessica R Allegretti, MD, MPH 617-732-6389
Contact: Madeline Carrellas 617-732-9223

United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jessica Allegretti, MD, MPH    617-732-6389   
Contact: Madeline Carrellas    617-732-9223   
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Christopher C Thompson, MD, MSC Brigham and Women's Hospital
Study Director: Jessica R Allegretti, MD, MPH Brigham and Women's Hospital
  More Information

Responsible Party: Christopher Thompson, Attending Physician, Brigham and Women's Hospital Identifier: NCT02741518     History of Changes
Other Study ID Numbers: 2016P000075
Study First Received: April 12, 2016
Last Updated: February 12, 2017

Keywords provided by Brigham and Women's Hospital:

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on May 25, 2017