Assessment of Changes in Gut Microbiota of Patients With Recurrent Clostridioides Difficile Infection After Fecal Microbiota Transplantation: Prospective Study

What this Trial Is About

Clostridioides difficile infection (CDI) is a common and serious health care-associated infection causing diarrhea, with recurrent CDI (rCDI) leading to increased hospital stays, higher rates of illness and death, and severe complications like sepsis and toxic megacolon. This research aims to study changes in gut microbiota composition in patients with rCDI after fecal microbiota transplantation (FMT) using metagenomics analysis to better understand how FMT works. The study involves a single-center observational design where patients with rCDI will receive FMT via colonoscopy using frozen feces from healthy donors selected according to established protocols. Stool samples will be collected before the procedure and during follow-up visits at weeks 1, 2, 4, and 12 to analyze microbiome changes. Donor feces preparation and transplantation follow international guidelines with no specific donor-recipient matching. Participants will be followed for three months after treatment, providing stool samples at each visit for microbiome and meta-transcriptome assessments. Researchers will evaluate both qualitative and quantitative changes in the gut microbiome at various time points, as well as monitor treatment-related adverse events. Data analysis will use statistical tests to compare microbiome characteristics before and after FMT, capturing outcomes up to 90 days post-treatment.

Changes in Recipients Gut Microbiota After Fecal Microbiota Transplantation