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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
27
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.
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.
Weill Cornell Medicine
New York, New York, United States
Clinical Response
Clinical response at week 8 post-FMT, as defined by the reduction of the Mayo scoring system by \>3 points (+30% reduction) with an accompanying decrease in the sub-score for rectal bleeding of at least 1 point
Time frame: Week 8 post-FMT
Clinical Remission
Clinical remission at week 8 post-FMT, as defined by Mayo score ≤ 2 without any subscore \>1
Time frame: Week 8 post-FMT
Endoscopic Response or Remission
Endoscopic response or remission at week 8 post-FMT, as defined by a Mayo endoscopic sub-score 0-1 with at least a 1-point reduction from baseline or a Mayo endoscopic sub-score of 0
Time frame: Week 8 post-FMT
Number of Treatment or Disease Related Adverse Events.
Adverse event counts are cumulative frequencies of adverse and severe adverse events assessed at Week 0 Colonoscopy - Week 12 post-FMT, 6 months post-FMT, and 1 year post-FMT.
Time frame: Week 0 Colonoscopy - Week 12 post-FMT, 6 months post-FMT, and 1 year post-FMT
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