The Effect of Fecal Microbiota Transplantation on the Decolonization of Multidrug-resistant Organisms

NCT04583098 | Completed

• 1 other identifier: 2020-08-006
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of fecal microbiota transplantation for the decolonization of carbapenem-resistant Enterobacteriaceae or vancomycin-resistant Enterococci in the gut.

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection; Vancomycin-Resistant Enterococcal Infection

Keywords

Fecal Microbiota Transplantation; Carbapenem-Resistant Enterobacteriaceae; Vancomycin-Resistant Enterococci; Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (1)

• successful decolonization of carbapenem-resistant Enterobacteriaceae or vancomycin-resistant Enterococci in the gut within 3 months after fecal microbiota transplantation

  Successful decolonization of carbapenem-resistant Enterobacteriaceae or vancomycin-resistant Enterococci was defined as three consecutive, carbapenem-resistant Enterobacteriaceae or vancomycin-resistant Enterococci-negative surveillance rectal swab cultures repeated with a 3-day interval within 3 months after fecal microbiota transplantation

  within 3 months

Study Arms (2)

carbapenem-resistant Enterobacteriaceae

FMT using frozen or capsulized stool

Other: fecal microbiota transplantation

vancomycin-resistant Enterococci

FMT using frozen or capsulized stool

Other: fecal microbiota transplantation

Interventions

fecal microbiota transplantation OTHER

frozen or capsulized stool from donors who had already finished recommended blood \& stool screening for stool donors

carbapenem-resistant Enterobacteriaceae; vancomycin-resistant Enterococci

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CRE- or VRE-rectal colonizer who have given written informed consent for fecal microbiota transplantation and collection of stool samples for CRE or VRE decolonization

You may qualify if:

• Patients over 19 years-old with carbapenem-resistant Enterobacteriaceae(CRE) or vancomycin-resistant Enterococci(VRE) rectal colonization
• Patients who have received written informed consent for fecal microbiota transplantation and collection of stool samples

You may not qualify if:

• Patients who have not completed acute-phase treatment, including antibiotic treatment
• If patients are pregnant, may be pregnant, or are lactating
• Patients who have not received written informed consent for the study enrollment
• Patients who are judged to be unhelpful to participate in the study according to the researcher's judgment

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

stool (gut microbiota)

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Seung Soon Lee, MD

  Chuncheon Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 12, 2020
• Study Start: March 14, 2019
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2024
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

KR (1)