NCT06001333 Efficacy and Safety of FMT for the Decolonization of MDROs in the Intestinal Tract
| NCT ID | NCT06001333 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chuncheon Sacred Heart Hospital |
| Condition | Carbapenem-Resistant Enterobacteriaceae |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-09-18 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2023-09-18 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Seung Soon Lee, MD, PhD
PRINCIPAL INVESTIGATOR
Chuncheon Sacred Heart Hospital
Frequently Asked Questions
Who can join the NCT06001333 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Carbapenem-Resistant Enterobacteriaceae. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06001333 currently recruiting?
Yes, NCT06001333 is actively recruiting participants. Contact the research team at hushh93@gmail.com for enrollment information.
Where is the NCT06001333 trial being conducted?
This trial is being conducted at Chuncheon, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06001333 clinical trial?
NCT06001333 is sponsored by Chuncheon Sacred Heart Hospital. The principal investigator is Seung Soon Lee, MD, PhD at Chuncheon Sacred Heart Hospital. The trial plans to enroll 240 participants.