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Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients

Clostridium Difficile Infection Clinical Trial

Official title:
A Phase II Randomized, Double-blind Placebo-controlled Trial of Fecal Microbiota Transplantation for Vancomycin-resistant Enterococcus and Carbapenem-resistant Enterobacteriaceae

Clinical Trial 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.

Clinical Trial Description

This is a phase II, double-blind, randomized, placebo controlled trial assessing the effects of one-time oral FMT on the composition and function of the gut microbiome compared to placebo in a population of patients with baseline CRE or VRE gut colonization. Participants will be adults who have had two consecutive positive stool cultures for VRE or CRE and meet all inclusion/exclusion criteria. Patients (N=90) will be randomized at a 1:1 ratio. Randomization will be double-blinded. Each subject will be followed for 6 months. Stool samples will be taken at baseline and from subjects weekly for 4 weeks, then every 4 weeks for 8 weeks, then at 6 months regardless of treatment group. All patients will be asked to complete a stool diary ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03643887
Study type Interventional
Source University of Wisconsin, Madison
Contact
Status Withdrawn
Phase Phase 2
Start date September 1, 2022
Completion date June 30, 2025
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