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 (FORCE)

NCT07106580 Phase 1/Phase 2 RECRUITING

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

Details

Lead sponsor	University of Rijeka
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	48
Start date	2025-07-28
Completion	2026-07

Conditions

• Colonization, Asymptomatic

Interventions

• lyophilized FMT capsules
• Placebo capsules

Primary outcomes

• Efficacy (decolonization on visit 7) — Day 180 ± 7 from randomization
  Decolonization on day 180 as determined by microbiological analysis. Rectal swabs or stool samples will be collected during each of the scheduled visits. Stool samples are preferred and are self-collected by participants. If stool sample is unavailable, a rectal swab will be collected. The samples will be promptly delivered to the local microbiology laboratory and processed using standard laboratory procedures.

Countries

Croatia