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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01112995
First received: April 27, 2010
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Infection
Dietary Supplement: Lactobacillus rhamnosus
Dietary Supplement: Sugar pill (placebo)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

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. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of clinical infections will be assessed in the one year following enrollment into the study [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 49
Study Start Date: January 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112995

Contacts
Contact: Nasia Safdar, MD, Ph.D (608)263-1545 ns2@medicine.wisc.edu
Contact: Prerna Panjikar, BS (608)262-4549 ppanjikar@medicine.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Hospital Recruiting
Madison, Wisconsin, United States, 53792
Contact: Nasia Safdar, MD, Ph.D    608-265-9790    ns2@medicine.wisc.edu   
Contact: Prerna Panjikar, BS    608-262-4549    ppanjikar@medicine.wisc.edu   
Principal Investigator: Nasia Safdar, MD, Ph.D         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Nasia Safdar, MD, Ph.D University of Wisconsin Department of Medicine (Infectious Disease)
  More Information

No publications provided

Responsible Party: Nasia Safdar, University of Wisconsin, Department of Medicine (Infectious Disease)
ClinicalTrials.gov Identifier: NCT01112995     History of Changes
Other Study ID Numbers: 2008-0023
Study First Received: April 27, 2010
Last Updated: April 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Probiotic
Lactobacillus
Antibiotic resistance

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014