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

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Anti-biotic Resistance

Treatments: Dietary Supplement: sugar pill (placebo); Dietary Supplement: VSL#3

Study type: Interventional

Funder types: Other

Identifiers

NCT00933556

H-2008-0023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

90 participants in 2 patient groups, including a placebo group

probiotic

Experimental group

Description:

subjects will be given a powder formulation of a probiotic VSL#3 to be taken once a day, at a dose of 6 gms

Treatment:

Dietary Supplement: VSL#3

sugar pill

Placebo Comparator group

Description:

placebo identical to the active product will be given

Treatment:

Dietary Supplement: sugar pill (placebo)