Using fecal microbiota transplantation to eliminate drug-resistant bacteria in the gut
Efficacy and Safety of Fecal Microbiota Transplantation for the Decolonization of Multidrug-Resistant Organisms in the Intestinal Tract: An Unblinded Randomized Controlled Trial
This study is testing if a treatment using healthy gut bacteria can help people get rid of tough drug-resistant infections in their intestines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chuncheon Sacred Heart Hospital Academic / other |
| Locations | 2 sites (Chuncheon, Gangwon-do and 1 other locations) |
| Trial ID | NCT06001333 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of fecal microbiota transplantation (FMT) for decolonizing the intestinal tract of patients infected with carbapenem-resistant Enterobacteriaceae (CPE) or vancomycin-resistant Enterococci (VRE). Participants will be randomly assigned to receive either FMT or standard care, with the primary goal of determining the success rate of decolonization one month after the procedure. Secondary outcomes will assess decolonization rates at three months, six months, and one year, as well as rates of reinfection. The study will involve careful patient preparation and monitoring to ensure safety and effectiveness.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and older with confirmed infections of CPE or VRE who have not taken antibiotics for 3-7 days prior to the procedure.
Not a fit: Patients currently undergoing antibiotic treatment, those with severe immunodeficiency, or individuals at risk from gastrointestinal procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the burden of multidrug-resistant infections in patients, improving their health outcomes.
How similar studies have performed: Previous studies have shown promising results with fecal microbiota transplantation for various gastrointestinal conditions, suggesting potential success for this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Individuals aged 20 and older. 2. Those with confirmed carbapenemase-producing Enterobacteriaceae (CPE) from a rectal swab culture within the past week (class A, B, or D CPE). 3. Those with confirmed vancomycin-resistant Enterococci (E. fecalis or E. faecium) from a rectal swab culture within the past week. 4. Individuals who have agreed to undergo Fecal Microbiota Transplantation (FMT) procedures and to provide pre- and post-procedure stool samples. 5. Individuals who have discontinued antibiotics for a period of 3 to 7 days prior to FMT procedure. Exclusion Criteria: 1. Patients with ongoing or anticipated acute treatment, including antibiotic therapy. 2. Individuals with severe immunodeficiency. 3. Cases where there is a risk due to upper gastrointestinal endoscopy or colonoscopy. 4. Pregnant individuals, those who could become pregnant, and breastfeeding women. 5. Cases where participation in the study is determined by the researcher not to be beneficial.
Where this trial is running
Chuncheon, Gangwon-do and 1 other locations
- Chuncheon Sacred Heart Hospital — Chuncheon, Gangwon-do, South Korea (Recruiting)
- Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Seung Soon Lee, MD, PhD — Chuncheon Sacred Heart Hospital
- Study coordinator: Seung Soon Lee, MD, PhD
- Email: hushh93@gmail.com
- Phone: +82-10-3379-9347
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.