A Pilot Trial to Determine the Efficacy of Lactobacillus Rhamnosus for Reducing Colonization by Methicillin-resistant Staphylococcus Aureus (MRSA) (PROSE) (PROSE)
Primary Purpose
Infection
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lactobacillus rhamnosus
Sugar pill (placebo)
Sponsored by
About this trial
This is an interventional prevention trial for Infection focused on measuring Probiotic, Lactobacillus, Antibiotic resistance
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
Sites / Locations
- University of Wisconsin Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic
Sugar pill
Arm Description
subjects will be given a pill formulation of a probiotic Lactobacillus rhamnosus to be taken once a day.
placebo identical to the active product will be given
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of clinical infections will be assessed in the one year following enrollment into the study
Full Information
NCT ID
NCT01112995
First Posted
April 27, 2010
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT01112995
Brief Title
A Pilot Trial to Determine the Efficacy of Lactobacillus Rhamnosus for Reducing Colonization by Methicillin-resistant Staphylococcus Aureus (MRSA) (PROSE)
Acronym
PROSE
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Probiotic, Lactobacillus, Antibiotic resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
subjects will be given a pill formulation of a probiotic Lactobacillus rhamnosus to be taken once a day.
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
placebo identical to the active product will be given
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus rhamnosus
Other Intervention Name(s)
Yoplait, Activia
Intervention Description
1 pill formulation to be given once a day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugar pill (placebo)
Other Intervention Name(s)
splenda
Intervention Description
placebo identical to the active product will be given
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence of clinical infections will be assessed in the one year following enrollment into the study
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasia Safdar, MD, Ph.D
Organizational Affiliation
University of Wisconsin Department of Medicine (Infectious Disease)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Trial to Determine the Efficacy of Lactobacillus Rhamnosus for Reducing Colonization by Methicillin-resistant Staphylococcus Aureus (MRSA) (PROSE)
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