Anti-biotic Resistance Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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