A Pilot Trial to Determine the Efficacy of VSL#3 for Reducing Colonization by VRE

Phase 2

Completed

• Conditions: Anti-biotic Resistance
• Interventions: Dietary Supplement: sugar pill (placebo); Dietary Supplement: VSL#3

• Registration Number: NCT00933556
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

The purpose of this study is to investigate the feasibility, safety and efficacy of oral probiotic, VSL#3 versus oral placebo for reducing colonization by VRE.

Detailed Description

Healthcare-associated infections are an important threat to patient safety. Currently, between 5 and 10 percent of patients admitted to acute care hospitals acquire one or more infections; healthcare-associated infections affect approximately 2 million patients each year in the United States, result in 90,000 deaths, and are associated with an added cost of $4.5 to $5.7 billion per year. Seventy percent of healthcare-associated infections are caused by antimicrobial resistant bacteria, such as vancomycin-resistant enterococcus (VRE), resulting in increased antimicrobial usage, morbidity and mortality, making prevention of multiresistant bacteria essential.

Eradication of colonization has been shown to greatly reduce infection; however, there are no reliable means of providing sustained eradication of colonization. No effective means of eradicating VRE intestinal colonization exist.

Probiotics containing strains of lactobacilli represent a novel approach to the prevention and control of antimicrobial resistance and have been studied extensively for a variety of infections. Even though various studies have shown probiotics to be effective for prevention of vaginal infections, urinary tract infections, etc no studies have examined the potential of probiotics to eradicate colonization by resistant pathogens, such as VRE.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Primary Completion: 2010-10
• Study Completion: 2012-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• subjects will be male or female
• 18 years of age or older
• may or may not be hospitalized
• able to take oral medications
• have been found to be colonized with VRE or at high risk of being colonized by VRE and are not taking antibiotics

Exclusion Criteria

• people on antibiotics will not be eligible to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	sugar pill (placebo)	placebo identical to the active product will be given
probiotic	VSL#3	subjects will be given a powder formulation of a probiotic VSL#3 to be taken once a day, at a dose of 6 gms

Primary Outcome Measures

Name	Time	Method
The main outcomes will be the proportion of patients colonized with VRE at 4 weeks, 8 weeks, 12 weeks and 24 weeks following start of treatment.	24 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of clinical infections will be assessed in the one year following enrollment into the study.	1 year

Trial Locations

Locations (1)

University of wisconsin hospital; 🇺🇸 Madison, Wisconsin, United States