RecruitingNot ApplicableNCT06001333

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

Efficacy and Safety of Fecal Microbiota Transplantation for the Decolonization of Multidrug-Resistant Organisms in the Intestinal Tract: An Unblinded Randomized Controlled Trial


Sponsor

Chuncheon Sacred Heart Hospital

Enrollment

240 participants

Start Date

Sep 18, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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Interventions

PROCEDUREfecal microbiota transplantation

Fecal microbiota transplantation will be conducted on patients using donor stool (frozen or capsulized stool) from a stool bank.


Locations(2)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Severance Hospital

Seoul, South Korea

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NCT06001333