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

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

January 31, 2020

Primary Completion Date

June 9, 2023

Study Completion Date

April 12, 2024

Conditions
Ulcerative ColitisInflammatory Bowel Diseases
Interventions
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."

Trial Locations (1)

10065

Weill Cornell Medicine, New York

All Listed Sponsors
collaborator

Crohn's and Colitis Foundation

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Weill Medical College of Cornell University

OTHER

NCT03998488 - Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis | Biotech Hunter | Biotech Hunter