A Pilot Trial to Determine the Efficacy of Lactobacillus Rhamnosus for Reducing Colonization by Methicillin-resistant Staphylococcus Aureus (MRSA) (PROSE)

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Infection

Treatments: Dietary Supplement: Lactobacillus rhamnosus; Dietary Supplement: Sugar pill (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT01112995

2008-0023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

subjects will be given a pill formulation of a probiotic Lactobacillus rhamnosus to be taken once a day.

Treatment:

Dietary Supplement: Lactobacillus rhamnosus

Sugar pill

Placebo Comparator group

Description:

placebo identical to the active product will be given

Treatment:

Dietary Supplement: Sugar pill (placebo)