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

A Pilot Randomized Trial to Determine the Efficacy of a Probiotic, VSL#3 for Reducing Colonization by Vancomycin-resistant Enterococcus (VRE)

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.

Study Overview

• Status: Completed
• Conditions: Anti-biotic Resistance
• Intervention / Treatment: Dietary supplement: VSL#3; Dietary supplement: sugar pill (placebo)

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: probiotic; subjects will be given a powder formulation of a probiotic VSL#3 to be taken once a day, at a dose of 6 gms	Dietary supplement: VSL#3; 6 gms of powder formulation to be given once a day for 4 weeks; Other Names: yoplait; activia
PLACEBO_COMPARATOR: sugar pill; placebo identical to the active product will be given	Dietary supplement: sugar pill (placebo); placebo identical to the active product will be given; Other Names: splenda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Incidence of clinical infections will be assessed in the one year following enrollment into the study.	1 year

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Nasia Safdar, MD, MS, University of Wisconsin Department of Medicine (Infectious Disease)

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 6, 2009
• First Posted (ESTIMATE): July 7, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 8, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: probiotics; infection
• Other Study ID Numbers: H-2008-0023