Randomized Trial of Fecal Microbiota Transplantation to Remove Carbapenem-resistant Enterobacteriaceae from the Gut

What this Trial Is About

Antimicrobial resistance is becoming a growing problem worldwide, with the gut microbiota acting as a major reservoir for antibiotic-resistance genes. Healthy gut bacteria help prevent harmful pathogens from colonizing the digestive tract, but treatments like antibiotics or chemotherapy can disrupt this balance, allowing multi-drug resistant bacteria MDRB, such as carbapenem-resistant Enterobacteriaceae CRE, to take hold. These bacteria pose health risks to both carriers and the wider community. Fecal microbiota transplantation FMT, a procedure transferring healthy donor bacteria into the gut, has shown promise in treating recurrent infections and may help eradicate MDRB colonization, though evidence so far is limited and inconclusive. This study is a randomized, placebo-controlled clinical trial comparing donor FMT with placebo FMT water delivered by colonoscopy in adults carrying CRE in their gut. Participants will be randomly assigned to receive either donor feces or placebo, with fecal material prepared and stored following strict guidelines. The study includes a single FMT procedure, with follow-up visits scheduled at 1, 2, 4, and 12 weeks after treatment to monitor colonization status and gut microbiome changes. Participants will have rectal swabs and stool samples collected at each visit to assess the presence of CRE and analyze microbiome diversity. Adverse events will be recorded throughout the 3-month follow-up period. The primary outcome is the number of participants who clear CRE carriage at 4 weeks, with secondary outcomes including clearance at 12 weeks, microbiome diversity changes, and treatment-related side effects. The study aims to provide clearer evidence on the effectiveness of FMT in eradicating MDRB colonization.

FMT for the Decolonization of Carbapenem-resistant Enterobacteriaceae