Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Inflammatory Bowel Diseases
- Ulcerative Colitis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Eligible subjects will be randomly assigned to one of the three (Placebo or Investigational FMT +/- Psyllium) treatment groups. A series of randomized blocks of 6-10 will be generated with a 1:1:1 allocation ratio.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: Double-blinded studyPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 89 years
- Gender
- Both males and females
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 s...
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.
Tracking Information
- NCT #
- NCT03998488
- Collaborators
- Crohn's and Colitis Foundation
- Investigators
- Principal Investigator: Randy Longman, MD, PhD Weill Medical College of Cornell University
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