RecruitingPhase 1Phase 2NCT07106580

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

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


Sponsor

University of Rijeka

Enrollment

48 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo capsules and lyophilized FMT capsules for people with colonization, asymptomatic. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERlyophilized FMT capsules

A total of 18 capsules containing 3060 mg of lyophilizate given through 3 days (three capsules twice daily)

OTHERPlacebo capsules

18 capsules of identical appearance and weight given in the same way as FMT capsules


Locations(1)

Clinical Hospital Center Rijeka

Rijeka, Croatia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07106580


Related Trials