Actively Recruiting
Efficacy and Safety of FMT for the Decolonization of MDROs in the Intestinal Tract
Led by Chuncheon Sacred Heart Hospital · Updated on 2025-06-19
240
Participants Needed
2
Research Sites
171 weeks
Total Duration
On this page
Sponsors
C
Chuncheon Sacred Heart Hospital
Lead Sponsor
S
Severance Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of FMT for the Decolonization of MDROs in the Intestinal Tract
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 20 and older
- Confirmed carbapenemase-producing Enterobacteriaceae (class A, B, or D) from rectal swab within the past week
- Confirmed vancomycin-resistant Enterococci (E. fecalis or E. faecium) from rectal swab within the past week
- Agreed to undergo fecal microbiota transplantation and provide stool samples before and after the procedure
- Discontinued antibiotics for 3 to 7 days prior to FMT procedure
You will not qualify if you...
- Receiving or expected to receive acute treatment including antibiotics
- Severe immunodeficiency
- Risk factors preventing safe upper gastrointestinal endoscopy or colonoscopy
- Pregnant, breastfeeding, or could become pregnant
- Participation deemed not beneficial by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea, 24253
Actively Recruiting
2
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
Research Team
S
Seung Soon Lee, MD, PhD
CONTACT
J
Jun Yong Choi, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here