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Completed

NCT Number: NCT02741518

Fecal Microbiota Transplantation for the Treatment of 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 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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Obesity defined as a BMI of 35kg/m2 or higher

Exclusion criteria

  • Triglycerides > 500 mg/dL
  • Use of antibiotics <8 weeks prior to participation
  • Use of probiotics <4 weeks prior to participation
  • Alcohol use of greater than 20g/daily or suspicion of alcohol abuse and dependence
  • Substance abuse, current
  • LFTS greater then 3x the ULN
  • Cirrhosis.
  • DM type 2 that is insulin dependent, treated with GLP1-agonists, or poorly controlled on oral medications (HbA1C > 10%)
  • Use of any weight loss medication or participation in a weight loss study or program such as Weight Watchers
  • 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
  • Patients who are pregnant or breastfeeding
  • Patients who are unable to give informed consent
  • 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

Treatment and study plan

Fecal microbiota transplantation

Biological

This is pre-screened fecal material that has been encapsulated

Other names: FMT

Placebo

Other

These are capsules that have no fecal material in them.

Primary outcomes

  1. Adverse Event Frequency

    Time frame: 6 months

    Number of patients reporting adverse events

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: FMT Obesity

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 18, 2016
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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