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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

July 2, 2009
March 21, 2011
October 2008
October 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00933556 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Pilot Trial to Determine the Efficacy of VSL#3 for Reducing Colonization by VRE
A Pilot Randomized Trial to Determine the Efficacy of a Probiotic, VSL#3 for Reducing Colonization by Vancomycin-resistant Enterococcus (VRE)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Anti-biotic Resistance
  • Dietary Supplement: VSL#3
    6 gms of powder formulation to be given once a day for 4 weeks
    Other Names:
    • yoplait
    • activia
  • Dietary Supplement: sugar pill (placebo)
    placebo identical to the active product will be given
    Other Name: splenda
  • 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
    Intervention: Dietary Supplement: VSL#3
  • Placebo Comparator: sugar pill
    placebo identical to the active product will be given
    Intervention: Dietary Supplement: sugar pill (placebo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
April 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00933556
2008- 0023
Yes
Nasia Safdar, University of Wisconsin, Department of Medicine (Infectious Disease)
University of Wisconsin, Madison
Not Provided
Principal Investigator: Nasia Safdar, MD, MS University of Wisconsin Department of Medicine (Infectious Disease)
University of Wisconsin, Madison
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP