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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02741518
Recruitment Status : Completed
First Posted : April 18, 2016
Results First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 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
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : October 18, 2018
Actual Study Completion Date : July 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment Arm
The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. 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
This is pre-screened fecal material that has been encapsulated
Other Name: FMT
Placebo Comparator: Placebo Arm
The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8
 Other: Placebo
These are capsules that have no fecal material in them.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Event Frequency [ Time Frame: 6 months ]
    Number of patients reporting adverse events


Secondary Outcome Measures :
  1. Assess Change of AUC of GLP-1 as a Therapeutic Biomarker for Clinical Response to Fecal Microbiota Transplantation From Baseline to Week 12 [ Time Frame: 12 weeks ]
    Fecal Microbiota Transplantation will lead to an increase in short chain fatty acids which will lead to an increase in the metabolic regulator GLP-1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Christopher C Thompson, MD, MSC Brigham and Women's Hospital
Study Director: Jessica R Allegretti, MD, MPH Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] May 16, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christopher C. Thompson, MD, MSc, Attending Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02741518    
Other Study ID Numbers: 2016P000075
First Posted: April 18, 2016    Key Record Dates
Results First Posted: January 7, 2020
Last Update Posted: January 7, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital:
obesity
FMT
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight