NCT03998488

Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis

A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, placebo-controlled clinical trial with the following treatment assignments: 1. Investigational FMT (one-time) 1. Subject will blindly receive investigational FMT once at day 0 colonoscopy 2. Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy. 2. Investigational FMT (one-time) + Psyllium (2x/day for 8 weeks) 1. Subject will blindly receive investigational FMT once at day 0 colonoscopy 2. Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy. 3. Placebo FMT (one-time) +/- Psyllium (2x/day for 8 weeks) 1. Subject will blindly receive placebo FMT once at day 0 colonoscopy 2. 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.

Conditions

• Ulcerative Colitis
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	Fecal Microbiota Transplantation	The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery.
DIETARY_SUPPLEMENT	Psyllium Husk Powder	All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.

Timeline

• Start date: 2020-01-31
• Primary completion: 2023-06-09
• Completion: 2024-04-12
• First posted: 2019-06-26
• Last updated: 2025-01-03
• Results posted: 2024-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study