Clinical Trial

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

Study acronym: FORCE
Recruiting Phase 1/2
View on ClinicalTrials.gov →
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
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-08-04; most recent amendment 2026-06-10.
Trial Details
NCT Number NCT07106580
Lead Sponsor University of Rijeka
Collaborators: Clinical Hospital Center Rijeka
Conditions Colonization, Asymptomatic
Enrollment 48 participants
Start Date 2025-07-28
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-15