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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
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection focused on measuring Probiotic, Lactobacillus, Antibiotic resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
April 27, 2010
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
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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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