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

Anti-biotic Resistance Clinical Trial

— PROVE  

Official title:

A Pilot Randomized Trial to Determine the Efficacy of a Probiotic, VSL#3 for Reducing Colonization by Vancomycin-resistant Enterococcus (VRE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933556
• Other study ID #: H-2008-0023
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2009
• Last updated: October 6, 2015
• Start date: October 2008
• Est. completion date: March 2012

Study information

• Verified date: October 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anti-biotic Resistance

Intervention

Dietary Supplement:
• VSL#3
6 gms of powder formulation to be given once a day for 4 weeks
• sugar pill (placebo)
placebo identical to the active product will be given

Locations

Country	Name	City	State
United States	University of wisconsin hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 weeks	Yes
Secondary	Incidence of clinical infections will be assessed in the one year following enrollment into the study.		1 year	No