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Efficacy and Safety of FMT for the Decolonization of MDROs in the Intestinal Tract

RecruitingNAAges 20 Years - anyAllChuncheon Sacred Heart Hospital
NCT06001333 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this unblinded randomized controlled trial is to evaluate the efficacy and safety of fecal microbiota transplantation for the decolonization of carbapenemase-producing carbapenem-resistant Enterobacteriaceae (CP-CRE) or vancomycin-resistant Enterococci (VRE) in the intestinal tract. The study is planned to be conducted to test the superiority hypothesis that the decolonization success rate in the FMT group is higher compared to the non-FMT group. Outcome analysis will be conducted through intention-to-treat analysis, modified intention-to-treat analysis, and per-protocol analysis. The main questions it aims to answer are: * primary endpoint: Rate of Decolonization of Multidrug-Resistant Organisms (CP-CRE or VRE) at 1 Month After Fecal Microbiota Transplantation (FMT). * secondary endpoint: Rates of Multidrug-Resistant Organism decolonization at 3 months, 6 months, and 1 yea

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Individuals aged 20 and older. 2. Those with confirmed carbapenemase-producing Enterobacteriaceae (CPE) from a rectal swab culture within the past week (class A, B, or D CPE). 3. Those with confirmed vancomycin-resistant Enterococci (E. fecalis or E. faecium) from a rectal swab culture within the past week. 4. Individuals who have agreed to undergo Fecal Microbiota Transplantation (FMT) procedures and to provide pre- and post-procedure stool samples. 5. Individuals who have discontinued antibiotics for a period of 3 to 7 days prior to FMT procedure. Exclusion Criteria: 1. Patients with ongoing or anticipated acute treatment, including antibiotic therapy. 2. Individuals with severe immunodeficiency. 3. Cases where there is a risk due to upper gastrointestinal endoscopy or colonoscopy. 4. Pregnant individuals, those who could become pregnant, and breastfeeding women. 5. Cases where participation in the study is determined by the researcher not to be beneficial.
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What it tests

  • fecal microbiota transplantation
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Where

2 sites
Chuncheon Sacred Heart Hospital
Chuncheon, South Korea
Severance Hospital
Seoul, South Korea
🤝 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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