Efficacy and Safety of FMT for the Decolonization of MDROs in the Intestinal Tract

Launched by CHUNCHEON SACRED HEART HOSPITAL · Aug 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called fecal microbiota transplantation (FMT) to see if it can help people get rid of certain harmful bacteria in their intestines, specifically carbapenem-resistant Enterobacteriaceae (CRE) and vancomycin-resistant Enterococci (VRE). The trial will compare two groups of participants: one group will receive FMT, which involves transferring healthy stool from a donor into their intestines, while the other group will not receive this treatment and will be observed. Researchers want to find out if the FMT group has a higher success rate in eliminating these resistant bacteria after one month and will keep track of their progress for up to a year.

To be eligible for the study, participants need to be 20 years or older and must have tested positive for either CRE or VRE from a recent rectal swab. They should also be able to stop taking antibiotics for a short period before the FMT procedure. Those with severe immune system issues, pregnant women, and individuals undergoing other significant treatments may not be able to participate. If someone joins the trial, they can expect regular check-ups to monitor their condition after the FMT, ensuring a thorough evaluation of the treatment's effectiveness and safety.

Gender

ALL

Eligibility 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.