Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis (MINDFUL)
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- STATUS
- Recruiting
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- End date
- Mar 23, 2024
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- participants needed
- 135
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- sponsor
- Weill Medical College of Cornell University
Summary
A double-blind, randomized, placebo-controlled clinical trial examining the efficacy and safety of Fecal Microbiota Transplantation (FMT) and high fiber supplementation in patients with active mild to moderate Ulcerative Colitis (UC). All enrolled subjects will provide serological, stool and mucosal specimen at each clinic visit to help further define the alterations in microbial profiles and immune cell function in response to psyllium fiber after FMT treatment.
Description
This is a randomized, double-blind, placebo-controlled clinical trial with the following treatment assignments:
- Investigational FMT (one-time)
- Subject will blindly receive investigational FMT once at day 0 colonoscopy
- Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy.
- Investigational FMT (one-time) + Psyllium (2x/day for 8 weeks)
- Subject will blindly receive investigational FMT once at day 0 colonoscopy
- Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy.
- Placebo FMT (one-time) +/- Psyllium (2x/day for 8 weeks)
- Subject will blindly receive placebo FMT once at day 0 colonoscopy
- Subjects in this group will blindly receive investigational FMP250 at week 8 by flexible sigmoidoscopy.
Subjects will blindly receive the investigational or placebo FMP250 treatment if they meet all inclusion and exclusion criteria during the day 0 screening colonoscopy. Subjects will receive follow-up phone calls at day 1, week 2, week 6, and week 10 post-FMT and will return for clinic visits at week 4, week 8 and week 12 post-FMT. Stool and blood samples will be collected for research purposes from subjects at every clinic visit (Day 0 colonoscopy, Week 4, Week 8, and Week 12). Mucosal biopsies will also be taken during the initial colonoscopy, at day 0 and during the follow-up flexible sigmoidoscopy at week 8. At week 8 post-FMT, all subjects will be evaluated by flexible sigmoidoscopy. Subjects originally randomized into the placebo cohort at week 0 will receive investigational FMP250 by flexible sigmoidoscopy at week 8, and subjects originally randomized into the investigational cohort at week 0 will receive placebo FMP250 by flexible sigmoidoscopy at week 8. Lastly, all subjects will be contacted for follow-up phone calls every subsequent 6 months for the next year.
Details
| Condition | Ulcerative Colitis, Inflammatory Bowel Diseases |
|---|---|
| Treatment | Fecal Microbiota Transplantation, Psyllium Husk Powder |
| Clinical Study Identifier | NCT03998488 |
| Sponsor | Weill Medical College of Cornell University |
| Last Modified on | 23 March 2022 |
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