Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Capsules for Intestinal Multidrug-resistant Organism Decolonization in Adults A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

What this Trial Is About

This research aims to evaluate whether oral capsules containing lyophilized stool from healthy donors, known as fecal microbiota transplantation (FMT), can safely and effectively remove multidrug-resistant organisms (MDROs) from the intestines of adults. MDROs such as ESBL-E, CRE, and VRE pose major health risks, including increased infection and transmission, especially in vulnerable groups. Current treatments have inconsistent success and risk promoting resistance, so this study explores FMT as a promising, non-antibiotic alternative. Participants will be randomly assigned to receive either oral FMT capsules containing lyophilized fecal microbiota from screened healthy donors or placebo capsules that look identical but contain an inert substance. The dosing involves 18 capsules over 3 days, taken as three capsules twice daily. The study is double-blind and placebo-controlled, ensuring neither participants nor researchers know which capsules are given. The intervention is delivered under supervision following protocols adapted from treatments for C. difficile infection. Participants will join for about 6 months, including a screening and baseline period with randomization and then four follow-up visits at days 7, 30, 90, and 180. During these visits, stool or rectal swab samples will be collected to test for MDRO presence, and participants will be monitored for side effects, infections, antibiotic use, and health changes. The main outcome is whether MDROs are cleared by day 180, along with safety and early decolonization at day 30. Continuous safety monitoring will address any adverse events throughout the study.

Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Via Capsules for Intestinal Multidrug-resistant Bacteria Decolonization