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
University of Rijeka
48 participants
Jul 28, 2025
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
Inclusion Criteria4
- ≥ 18 years,
- rectal swab positive for MDRO (including but not limited to: CRE, ESBL-E, VRE) within a week of randomization,
- capable of swallowing oral capsules,
- willing to give informed consent
Exclusion Criteria10
- antibiotic treatment on the day of inclusion,
- pregnant or breastfeeding, women of childbearing potential who are unwilling or unable to use an acceptable method of birth control,
- patients with terminal diseases with expected life expectancy < 6 months,
- unwillingness to ingest the capsules,
- a history of colectomy, present colostomy or ileostomy,
- patients with the diagnosis/treatment of inflammatory or functional bowel disease,
- patients with malignant bowel diseases,
- absolute neutrophil count < 500/mm3,
- selective digestive decolonization with antibiotics within 6 months before randomization,
- severe allergy to capsule components
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Interventions
A total of 18 capsules containing 3060 mg of lyophilizate given through 3 days (three capsules twice daily)
18 capsules of identical appearance and weight given in the same way as FMT capsules
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07106580