Fecal Microbiota Transplantation for the Treatment of Obesity

Obesity Clinical Trial

— FMT Obesity  

Official title:

Fecal Microbiota Transplantation for the Treatment of Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741518
• Other study ID #: 2016P000075
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 1, 2017
• Est. completion date: July 24, 2019

Study information

• Verified date: December 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 24, 2019
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Biological:
• Fecal Microbiota Transplantation
This is pre-screened fecal material that has been encapsulated

Other:
• Placebo
These are capsules that have no fecal material in them.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event Frequency	Number of patients reporting adverse events	6 months
Secondary	Assess Change of AUC of GLP-1 as a Therapeutic Biomarker for Clinical Response to Fecal Microbiota Transplantation From Baseline to Week 12	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	12 weeks