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

Recruiting now · Not applicable

Conditions studied: Carbapenem-Resistant Enterobacteriaceae, Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)

In brief

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.

Key facts

Study ID

NCT06001333

Run by

Chuncheon Sacred Heart Hospital

People needed

240

Starts

2023-09-18

Expected to finish

2026-12-31

Last updated by the study team

2025-06-19

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals aged 20 and older.
• Those with confirmed carbapenemase-producing Enterobacteriaceae (CPE) from a rectal swab culture within the past week (class A, B, or D CPE).
• Those with confirmed vancomycin-resistant Enterococci (E. fecalis or E. faecium) from a rectal swab culture within the past week.
• Individuals who have agreed to undergo Fecal Microbiota Transplantation (FMT) procedures and to provide pre- and post-procedure stool samples.
• Individuals who have discontinued antibiotics for a period of 3 to 7 days prior to FMT procedure.

You may not qualify if…

• Patients with ongoing or anticipated acute treatment, including antibiotic therapy.
• Individuals with severe immunodeficiency.
• Cases where there is a risk due to upper gastrointestinal endoscopy or colonoscopy.
• Pregnant individuals, those who could become pregnant, and breastfeeding women.
• Cases where participation in the study is determined by the researcher not to be beneficial.

Where it is running

• Chuncheon Sacred Heart Hospital — Chuncheon, Gangwon-do, South Korea (enrolling)
• Severance Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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