Efficacy and Mechanisms of Fecal Microbiota Transplantation to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae

What this Trial Is About

Antibiotic resistance (AR), especially involving multi-drug-resistant bacteria (MDRB) like carbapenem-resistant Enterobacteriaceae (CRE), is a serious public health threat causing many infections and deaths. The gut is a key reservoir for these resistant bacteria, and healthy gut microbiota can help prevent their colonization. This research investigates whether fecal microbiota transplantation (FMT) from donors with low levels of AR genes can help eradicate intestinal CRE compared to placebo, while also exploring the microbial factors linked to treatment success. The study is a single-center, randomized, placebo-controlled, double-blind trial where 36 patients colonized with CRE will be randomly assigned to receive a single colonoscopic FMT procedure from selected donors or a placebo (water). Donors are healthy individuals with minimal antibiotic exposure, screened for low resistance gene presence. Patients will be followed for 12 weeks after treatment, with stool and rectal swab samples collected at baseline and weeks 1, 4, and 12 for microbial and resistance gene analysis. Participants will undergo clinical visits and stool sample collections at scheduled follow-ups to monitor CRE eradication and microbiome changes. The primary outcome is CRE clearance at 4 weeks post-treatment, with secondary outcomes including eradication at weeks 1 and 12 and microbiome alterations. Advanced analysis methods, including machine learning, will be used to identify microbial profiles linked to treatment response. The study aims to develop targeted microbiome therapies against resistant bacteria and reduce the burden of antibiotic resistance.

FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae