Fecal microbiota transplantation for decolonizing drug-resistant infections
The Effect of Fecal Microbiota Transplantation on the Decolonization of Carbapenem-resistant Enterobacteriaceae or Vancomycin-resistant Enterococci in the Gut
Chuncheon Sacred Heart Hospital · NCT04583098
This study is testing if a treatment using donated stool can help people get rid of drug-resistant infections in their gut.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chuncheon Sacred Heart Hospital (other) |
| Locations | 1 site (Chuncheon, Gangwon-do) |
| Trial ID | NCT04583098 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate the effectiveness of fecal microbiota transplantation (FMT) in patients colonized with carbapenem-resistant Enterobacteriaceae (CRE) and vancomycin-resistant Enterococci (VRE). Participants will undergo a bowel preparation and receive FMT using frozen donor stool from a screened stool bank. The study will assess the impact of FMT on the decolonization of these multidrug-resistant organisms in the gut. Written consent is required from all participants, and the procedure will be conducted under the supervision of a gastroenterology research team.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old who are colonized with CRE or VRE and have provided informed consent.
Not a fit: Patients who have not completed acute-phase treatment or are pregnant, lactating, or unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel method for eliminating multidrug-resistant organisms from the gut, improving patient outcomes.
How similar studies have performed: While the use of fecal microbiota transplantation is gaining traction, this specific application for decolonizing multidrug-resistant organisms is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chuncheon, Gangwon-do
- Chuncheon Sacred Heart Hospital — Chuncheon, Gangwon-do, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Seung Soon Lee, MD — Chuncheon Sacred Heart Hospital
- Study coordinator: Seung Soon Lee, MD
- Email: hushh93@gmail.com
- Phone: +82-33-240-5599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Carbapenem-Resistant Enterobacteriaceae Infection, Vancomycin-Resistant Enterococcal Infection, Fecal Microbiota Transplantation, Carbapenem-Resistant Enterobacteriaceae, Vancomycin-Resistant Enterococci, Gastrointestinal Microbiome