NCT03643887

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	FMT Capsule DE	30 capsule one-time oral dose
DRUG	Placebo oral capsule	30 capsule one-time oral dose

Timeline

• Start date: 2022-09-01
• Primary completion: 2022-09-01
• Completion: 2025-06-30
• First posted: 2018-08-23
• Last updated: 2021-02-23