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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllUniversity of Rijeka
NCT07106580 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * ≥ 18 years, * stool sample or rectal swab positive for MDRO (CRE, ESBL-E, VRE) within a week of randomization, * capable of swallowing oral capsules, * willing to give informed consent Exclusion Criteria: * 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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What it tests

  • lyophilized FMT capsules
  • Placebo capsules
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Where

1 site
Clinical Hospital Center Rijeka
Rijeka, Croatia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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