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

Study Overview
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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.

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.

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

Conditions
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Anti-biotic Resistance

Intervention / Treatment
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* Dietary Supplement: VSL#3
* Dietary Supplement: sugar pill (placebo)


Participation Criteria
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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 Exclusion Criteria: people on antibiotics will not be eligible to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic<br>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<br>* 6 gms of powder formulation to be given once a day for 4 weeks<br>* Other names: activia;|
| Placebo Comparator: sugar pill<br>placebo identical to the active product will be given | Dietary Supplement: sugar pill (placebo)<br>* placebo identical to the active product will be given<br>* Other names: splenda;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, probiotics