A Pilot Randomized Trial to Determine the Efficacy of a Probiotic, Lactobacillus Rhamnosus for Reducing Colonization by Methicillin-resistant Staphylococcus Aureus (MRSA)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Infection
- Sponsor
- University of Wisconsin, Madison
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- The main outcomes will be the proportion of patients colonized with MRSA at 4 weeks, 8 weeks, 12 weeks and 24 weeks following start of treatment.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to investigate the feasibility, safety and efficacy of oral probiotic, Lactobacillus rhamnosus versus oral placebo for reducing colonization by MRSA.
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 methicillin-resistant Staphylococcus aureus (MRSA), 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 MRSA 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 MRSA.
Investigators
Eligibility Criteria
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 MRSA or at high risk of being colonized by MRSA and are not taking antibiotics
Exclusion Criteria
- •people on antibiotics will not be eligible to participate
Outcomes
Primary Outcomes
The main outcomes will be the proportion of patients colonized with MRSA at 4 weeks, 8 weeks, 12 weeks and 24 weeks following start of treatment.
Time Frame: 24 weeks
Secondary Outcomes
- Incidence of clinical infections will be assessed in the one year following enrollment into the study(1 year)