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Clinical Trials in South Korea / NCT06001333
Recruiting Not applicable

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

NCT06001333 · tracked via the Priya Life Science South Korea tracker
Sponsor
Chuncheon Sacred Heart Hospital
Phase
Not applicable
Started
2023-09-18
Last updated
2025-06-19

Condition(s) studied

Carbapenem-Resistant EnterobacteriaceaeVancomycin (Glycopeptide) Resistant Enterococcus (VRE)

Investigational drug(s) / intervention(s)

fecal microbiota transplantation

fecal microbiota transplantation: Fecal microbiota transplantation will be conducted on patients using donor stool (frozen or capsulized stool) from a stool bank.

Study summary

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 year after FMT / Post-FMT Multidrug-Resistant Organism Recolonization Rate and Infection Rate.

Patients colonized with multidrug-resistant organisms in the gastrointestinal tract are divided into two groups through obtaining written consent from the patients and random allocation: the Fecal Microbiota Transplantation group (FMT group), which receives FMT, and the control group (non-FMT group), which is observed without FMT. The decolonization status of multidrug-resistant organisms will be monitored every 3-7 days after FMT until three consecutive negative results.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Rate of Decolonization of Multidrug-Resistant Organisms at 1 Month After Fecal Microbiota Transplantation (FMT) — at 1 Month After Fecal Microbiota Transplantation (FMT)
    The decolonization rate at 1 month after FMT refers to the proportion of achieving three consecutive negative results within 1 month after the FMT procedure.

Trial sites (2)

FacilityCityRegionStatus
Chuncheon Sacred Heart Hospital Chuncheon Gangwon-do Recruiting
Severance Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06001333 on ClinicalTrials.gov ↗ ← All trials in South Korea