Fecal Microbiota Transplantation for the Treatment of Obesity

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-07-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Fecal Microbiota Transplantation

Intervention Type BIOLOGICAL

This is pre-screened fecal material that has been encapsulated

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

These are capsules that have no fecal material in them.

Interventions

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Fecal Microbiota Transplantation

This is pre-screened fecal material that has been encapsulated

Intervention Type BIOLOGICAL

Placebo

These are capsules that have no fecal material in them.

Intervention Type OTHER

Other Intervention Names

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FMT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No