Phase III Study of Capsule-Delivered Fecal Microbiota Transplantation to Remove Drug-Resistant Gram Negative Bacteria Carriage

What this Trial Is About

Researchers are investigating the use of fecal microbiota transplantation FMT capsules as a way to clear multi-drug resistant and extensively drug-resistant Gram-negative bacteria MDR-GNB from the gut. These bacteria are a serious global health threat because they increase the risk of infections and spread easily in healthcare and community settings. This phase III randomized controlled trial aims to see if FMT capsules can effectively decolonize patients carrying carbapenem-resistant or extended-spectrum beta-lactamase producing Enterobacteriaceae, which currently have limited treatment options. The study compares two groups one receiving FMT capsules made from healthy donor stool processed and frozen into capsules, and the other receiving placebo capsules containing only the solution used in FMT preparation. Participants will take 50 capsules in one day. This capsule form helps reduce side effects and supports outpatient treatment. The trial will assess the effect of FMT capsules versus placebo on bacterial decolonization and infection prevention over time. Participants will be monitored through stool cultures taken at the start, 30 days, and 90 days after treatment to check for bacterial clearance. Secondary assessments will track infection rates, safety, and tolerability for up to two years. The study includes detailed monitoring of microbiological and clinical outcomes, with the primary measure being clearance of MDR-GNB at 30 days post-randomization. The total follow-up may extend to two years to evaluate long-term effects and safety.

Fecal Transplantation to Eradicate Colonizing Emergent Superbugs