Lyophilised faecal microbiota transplantation capsules for intestinal multidrug-resistant organism decolonisation: protocol for a randomised, double-blind, placebo-controlled trial.

Abstract

Antimicrobial resistance is a major global health threat. Intestinal carriage of multidrug-resistant organisms (MDRO) increases the risk of subsequent infection and contributes to onward transmission. Current decolonisation strategies are limited by insufficient evidence of efficacy and safety. Faecal microbiota transplantation (FMT) has emerged as a potential microbiota-based approach for intestinal MDRO decolonisation, but available evidence remains heterogeneous and data on lyophilised capsule formulations are scarce. This study aims to evaluate the efficacy and safety of oral lyophilised FMT capsules for intestinal decolonisation of MDROs in adults. This is a single-centre, randomised, double-blind, placebo-controlled trial that will enrol 48 adults with confirmed intestinal carriage of MDROs. Participants will be randomised in a 1:1 ratio to receive either lyophilised FMT capsules or matching placebo capsules. The intervention consists of 18 gastro-resistant capsules administered over three consecutive days. Participants will be followed for 180 days, with study visits on days 7, 30, 90 and 180. The primary outcome is the proportion of participants without intestinal MDRO carriage at day 180, determined by stool sample or rectal swab culture. Secondary outcomes include early decolonisation at day 30, time to decolonisation, incidence of MDRO-related infections and safety outcomes including adverse events. Analyses will be performed primarily on an intention-to-treat basis, with prespecified sensitivity analyses for missing outcome data. The study has been approved by the Ethics Committee of the Clinical Hospital Centre Rijeka, the Ethics Committee of the Teaching Institute of Public Health of Primorsko-Goranska County, and the Ethics Committee for Biomedical Research of the Faculty of Medicine, University of Rijeka. Written informed consent will be obtained from all participants before enrolment. Study findings will be disseminated through peer-reviewed publications and presentations at scientific meetings. NCT07106580.