A Pilot Trial to Determine the Efficacy of VSL#3 for Reducing Colonization by VRE (PROVE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Wisconsin, Madison.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00933556
First received: July 2, 2009
Last updated: March 21, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to investigate the feasibility, safety and efficacy of oral probiotic, VSL#3 versus oral placebo for reducing colonization by VRE.


Condition Intervention Phase
Anti-biotic Resistance
Dietary Supplement: VSL#3
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, VSL#3 for Reducing Colonization by Vancomycin-resistant Enterococcus (VRE)

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

Primary Outcome Measures:
  • The main outcomes will be the proportion of patients colonized with VRE 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: 50
Study Start Date: October 2008
Estimated Study Completion Date: April 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: probiotic
subjects will be given a powder formulation of a probiotic VSL#3 to be taken once a day, at a dose of 6 gms
Dietary Supplement: VSL#3
6 gms of powder 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 vancomycin-resistant enterococcus (VRE), 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 VRE intestinal 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 VRE.

  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 VRE or at high risk of being colonized by VRE and are not taking antibiotics

Exclusion Criteria:

  • people on antibiotics will not be eligible to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933556

Locations
United States, Wisconsin
University of wisconsin hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Nasia Safdar, MD, MS 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: NCT00933556     History of Changes
Other Study ID Numbers: 2008- 0023
Study First Received: July 2, 2009
Last Updated: March 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
infection
probiotics

ClinicalTrials.gov processed this record on April 17, 2014