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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
30 capsule one-time oral dose
30 capsule one-time oral dose
Compare incidence of VRE/CRE decolonization between FMT Capsule double encapsuled (DE) and placebo
VRE/CRE decolonization is defined by absence of VRE/CRE on stool culture using standard laboratory techniques.
Time frame: 6 months
VRE/CRE infection at Day 3, Day 10, and Week 4 following randomization.
VRE/CRE infection will be defined as an associated bacteremia, urinary tract infection, or would-related infection.
Time frame: 1 month
Microbial engraftment assessed by microbial disruption index (MDI) at Day 3, Day 10, and Week 4 following randomization
VRE/CRE type and strain level engraftment, using whole genome sequencing laboratory techniques
Time frame: 1 month
Antibiotic resistant bacteria (ARB) decolonization at Day 10 after randomization.
ARB testing will be done with Acuitas (OpGen) MDRO test or a similar platform
Time frame: 10 days
Antibiotic resistant bacteria (ARB) infection at Day 3, Day 10, Week 4 after randomization, and time to infection if ARB infection occurs
ARB infection will be defined as extended spectrum beta lactamase clinical infection.
Time frame: 1 month
Adverse events/serious adverse events through Day 10, Week 4, and Month 6 following randomization.
Safety of FMT Capsule DE compared to placebo. Incidence of newly acquired transmissible infectious diseases that are considered adverse events of special interest (AESI).
Time frame: 6 months
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