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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anti-biotic Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

VSL#3

Intervention Type DIETARY_SUPPLEMENT

6 gms of powder formulation to be given once a day for 4 weeks

sugar pill

placebo identical to the active product will be given

Group Type PLACEBO_COMPARATOR

sugar pill (placebo)

Intervention Type DIETARY_SUPPLEMENT

placebo identical to the active product will be given

Interventions

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VSL#3

6 gms of powder formulation to be given once a day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

sugar pill (placebo)

placebo identical to the active product will be given

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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yoplait activia splenda

Eligibility Criteria

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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