Safety Registry of a Fecal Microbiota Transplant Cohort (COSMIC-FMT) for Clostridium difficile Infection

What this Trial Is About

Clostridium difficile infection (CDI) is a leading cause of infectious diarrhea, especially in hospitals, and recurrent infections are a significant challenge. The incidence and severity of CDI have increased over the past decades, with higher mortality and complications. Recurrent CDI causes repeated hospitalizations and serious health effects. This study aims to collect data on patients receiving fecal microbiota transplantation (FMT) for CDI and on stool donors in France to evaluate the safety, methods, effectiveness, and side effects of FMT in routine care. The study observes adult patients who are planned to receive FMT as part of their usual treatment for severe or recurrent CDI, following European guidelines. It also includes adult stool donors who provide samples for transplantation. The study gathers information over several years, tracking hospitalizations related to FMT, relapse and reinfection rates, and how the clinical characteristics of donors and patients, as well as preparation methods, affect outcomes. Microbiota composition and immune profiles are also analyzed before and after treatment. Participants will be followed for up to three years after FMT. Researchers will monitor stool frequency and consistency, body mass index changes, and recurrence or reinfection of CDI. The study records adverse events at multiple time points, including 24 hours, 10 weeks, and every six months up to three years. Data collection includes microbiota sequencing, metabolomic, and immunological analyses to understand the treatment's impact and safety in this population.

Safety Registry of a Fecal Microbiota Transplant Cohort