27
Participants
Start Date
January 31, 2020
Primary Completion Date
June 9, 2023
Study Completion Date
April 12, 2024
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."
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."
Weill Cornell Medicine, New York
Crohn's and Colitis Foundation
OTHER
National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Weill Medical College of Cornell University
OTHER