Study of Fecal Microbiota Transplant Capsules to Treat Recurrent Clostridioides Difficile Infection in Adults

What this Trial Is About

Researchers are evaluating the use of fecal microbiota transplantation FMT capsules to treat recurrent Clostridioides difficile infection rCDI in a double-blind randomized controlled trial. The study aims to assess the effectiveness and safety of these capsules in patients who have experienced multiple recurrences of CDI. It will also explore whether stool antigen tests or clinical risk factors can help identify which patients are most likely to benefit from this treatment. Participants will be randomly assigned to receive either capsules containing healthy donor stool or placebo capsules produced by a standardized method. The study includes 76 patients who have had recurrent CDI, and the treatments will be given orally in capsule form. The trial is designed to compare outcomes between the active FMT group and the placebo group over a 12-week period following treatment. During the study, participants will be monitored for recurrence of CDI by stool tests and symptoms of diarrhea. Safety will be assessed by tracking any side effects at one, four, and twelve weeks after treatment. The main outcome measured is the number of patients who experience CDI recurrence within 12 weeks after receiving either the FMT capsules or placebo. The study will continue through 2030, with follow-up visits and evaluations to ensure participant safety and treatment adherence.

FMT Capsules for rCDI