Comparing Fecal Microbiota Transplantation and Antibiotic Treatment for First Episode or First Recurrence of Clostridioides difficile Infection

What this Trial Is About

This trial focuses on adults with Clostridioides difficile infection CDI, including those experiencing their first episode with risk factors for recurrence or their first recurrence. Researchers aim to compare the effectiveness of fecal microbiota transplantation FMT combined with standard antibiotic treatment against standard antibiotic treatment alone, to prevent further CDI recurrences. This Phase III, randomized, open-label trial addresses an important challenge since recurrent CDI causes significant health problems and reduced quality of life. Participants are randomly assigned to one of two groups. One group receives standard oral antibiotics vancomycin or fidaxomicin for 10 days, followed by FMT capsules administered over two consecutive days patients with severe CDI receive a second FMT over the next two days. The other group continues with the standard antibiotic treatment alone for 10 days. The FMT capsules are prepared from healthy donors and given orally after a brief antibiotic pause. Throughout the study, participants are monitored for sustained clinical cure assessed 8 weeks after treatment completion, with follow-up lasting 12 months. Researchers evaluate treatment failure, new CDI episodes, long-term cure rates, recurrence-free survival, overall survival, and health status using standardized questionnaires. The study aims to gather comprehensive data on the safety and efficacy of FMT combined with standard antibiotics in preventing CDI recurrence.

Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence