Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients
Status:
Withdrawn
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
Summary
Vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE) are
multi-drug resistant organisms (MDROs) associated with healthcare settings and are a high
priority for containment in public health. Healthcare-associated infections (HAIs) like VRE
and CRE lengthen the duration of a hospital stay, increase the cost of hospitalization, and
increase mortality. Because colonization precedes infection, prevention or treatment of
VRE/CRE colonization is essential. We propose a treatment approach to promote gut
decolonization by VRE and CRE without using antibiotics. Participants enrolled in this study
will be randomized a one-time dose of either study drug or placebo, will be followed for 6
months, and will submit stool samples for analysis of several outcomes for the trial.