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.
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.
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.
Parallel
fecal microbiota transplantation
Procedure/SurgeryFecal microbiota transplantation will be conducted on patients using donor stool (frozen or capsulized stool) from a stool bank.
Rate of Decolonization of Multidrug-Resistant Organisms 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.
rates of Multidrug-Resistant Organism decolonization at 3 months, 6 months, and 1 year after Fecal Microbiota Transplantation (FMT)
The decolonization rate at 1 month, 3 months, and 1 year after FMT refers to the proportion of achieving three consecutive negative results within 3 months, 6 months, and 12 months after the FMT procedure.
Post-FMT Multidrug-Resistant Organism Recolonization Rate and Infection Rate within 1 year after FMT
The rates of re-colonization of decolonized multidrug-resistant organisms (CP-CRE or VRE) and clinical infection rates of MDROs within 1 year after FMT procedure.
Click on the lead sponsor to view all of their trials.
Chuncheon Sacred Heart Hospital
Lead sponsor
Severance Hospital
Collaborator
National Institute of Health, Korea
Collaborator
