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

Sponsor

Chuncheon Sacred Heart Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04583098

Collaborator

(none)

100

Enrollment

Location

36.5

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carbapenem-Resistant Enterobacteriaceae Infection Vancomycin-Resistant Enterococcal Infection	Other: fecal microbiota transplantation

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Effect of Fecal Microbiota Transplantation on the Decolonization of Carbapenem-resistant Enterobacteriaceae or Vancomycin-resistant Enterococci in the Gut

Actual Study Start Date :

Mar 14, 2019

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
carbapenem-resistant Enterobacteriaceae	Other: fecal microbiota transplantation frozen stool from donors who had already finished recommended blood & stool screening for stool donors
vancomycin-resistant Enterococci	Other: fecal microbiota transplantation frozen stool from donors who had already finished recommended blood & stool screening for stool donors

Arm

Intervention/Treatment

carbapenem-resistant Enterobacteriaceae

Other: fecal microbiota transplantation

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

vancomycin-resistant Enterococci

Other: fecal microbiota transplantation

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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