Clinical Research Directory

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

Sponsor: University of Rijeka

Summary

The goal of this clinical trial is to learn if oral capsules containing lyophilized stool from healthy donors (fecal microbiota transplantation or FMT) can safely and effectively decolonize multidrug-resistant organisms (MDROs) from the intestines in adults. The main questions it aims to answer are: 1. Does FMT via oral capsules reduce or eliminate intestinal MDRO colonization? 2. What side effects or adverse events occur after taking FMT capsules? Researchers will compare FMT capsules to placebo capsules to see if FMT is effective and safe for decolonizing MDROs. Participants will: * Take either FMT capsules or placebo capsules by mouth * Attend 4 follow-up study visits over 6 months (180 days) for microbiological testing and safety monitoring * Provide stool samples and report any side effects

Official title: A Monocentric, Prospective, Randomized, Placebo-controlled, Double-blinded Trial Investigating the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Capsules in Decolonization of Patients With Intestinal Carriage of Multidrug-resistant Organisms

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