Status:
RECRUITING
Efficacy and Safety of FMT for the Decolonization of MDROs in the Intestinal Tract
Lead Sponsor:
Chuncheon Sacred Heart Hospital
Collaborating Sponsors:
Severance Hospital
National Institute of Health, Korea
Conditions:
Carbapenem-Resistant Enterobacteriaceae
Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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...
Detailed Description
The study is planned to be conducted at Chuncheon Sacred Heart Hospital and Severance Hospital, using randomization with equal allocation to allocate patients into FMT (Fecal Microbiota Transplantatio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06001333
Start Date
September 18 2023
End Date
December 31 2026
Last Update
June 19 2025
Active Locations (2)
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1
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea, 24253
2
Severance Hospital
Seoul, South Korea, 03722