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

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ClinicalTrials.gov Identifier: NCT02741518
Recruitment Status : Recruiting
First Posted : April 18, 2016
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Obesity Biological: Fecal Microbiota Transplantation Other: Placebo Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for the Treatment of Obesity
Study Start Date : November 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741518


Contacts
Contact: Jessica R Allegretti, MD, MPH 617-732-6389 jallegretti@partners.org
Contact: Madeline Carrellas 617-732-9223 mcarrellas@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jessica Allegretti, MD, MPH    617-732-6389    jallegretti@partners.org   
Contact: Madeline Carrellas    617-732-9223    mcarrellas@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT02741518     History of Changes
Other Study ID Numbers: 2016P000075
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Christopher Thompson, Brigham and Women's Hospital:
obesity
FMT

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms