Fecal Microbiota Transplantation in Initial Clostridioides Difficile Enteritis: a Randomized, Placebo-controlled Trial

What this Trial Is About

Clostridioides difficile infection (CDI) is a challenging condition often caused by damage to the gut microbiota after antibiotic use, leading to infection and possible recurrence. This research evaluates fecal microbiota transplantation (FMT) via a retention enema after the first CDI episode to see if it can reduce relapse rates and improve bowel function compared to placebo. The study is a randomized, placebo-controlled trial sponsored by Turku University Hospital, focusing on an earlier and less invasive approach than the standard colonoscopy FMT given after multiple CDI recurrences. Participants receive either FMT enema, which involves transferring healthy gut bacteria from a tested donor, or a placebo enema of colored water. The FMT is administered 3 to 5 days after standard antibiotic treatment for CDI. This trial compares these two groups to assess the effectiveness and safety of this simpler, cost-effective method. The study uses triple masking to ensure unbiased results. During the study, participants will be monitored for CDI relapse up to one year, gastrointestinal symptoms, gut microbiota composition, and potential adverse events related to FMT. Other assessments include retention time of the enema, mood and anxiety scores, and quality of life measures. Adherence to treatment and safety are tracked from recruitment through administration and follow-up. The total duration includes assessments at 3 months and 1 year after treatment.

FMT in Initial CDI