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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01112995
Recruitment Status : Completed
First Posted : April 29, 2010
Last Update Posted : October 5, 2015
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Infection Dietary Supplement: Lactobacillus rhamnosus Dietary Supplement: Sugar pill (placebo) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Randomized Trial to Determine the Efficacy of a Probiotic, Lactobacillus Rhamnosus for Reducing Colonization by Methicillin-resistant Staphylococcus Aureus (MRSA)
Study Start Date : January 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA

Arm Intervention/treatment
Experimental: Probiotic
subjects will be given a pill formulation of a probiotic Lactobacillus rhamnosus to be taken once a day.
Dietary Supplement: Lactobacillus rhamnosus
1 pill formulation to be given once a day for 4 weeks
Other Names:
  • Yoplait
  • Activia

Placebo Comparator: Sugar pill
placebo identical to the active product will be given
Dietary Supplement: Sugar pill (placebo)
placebo identical to the active product will be given
Other Name: splenda

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of clinical infections will be assessed in the one year following enrollment into the study [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01112995

United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Nasia Safdar, MD, Ph.D University of Wisconsin Department of Medicine (Infectious Disease)

Responsible Party: University of Wisconsin, Madison Identifier: NCT01112995     History of Changes
Other Study ID Numbers: 2008-0023
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: April 2011

Keywords provided by University of Wisconsin, Madison:
Antibiotic resistance

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents