Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT06001333

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

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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

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