Impact of Probiotics for Reducing Infections in Veterans (IMPROVE): Study protocol for a double-blind, randomized controlled trial to reduce carriage of Staphylococcus aureus

Shoshannah Eggers; Anna Barker; Susan Valentine; Timothy Hess; Megan Duster; Nasia Safdar

doi:10.1016/j.cct.2016.11.004

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Impact of Probiotics for Reducing Infections in Veterans (IMPROVE): Study protocol for a double-blind, randomized controlled trial to reduce carriage of Staphylococcus aureus

Journal article

Peer reviewed

Impact of Probiotics for Reducing Infections in Veterans (IMPROVE): Study protocol for a double-blind, randomized controlled trial to reduce carriage of Staphylococcus aureus

Shoshannah Eggers, Anna Barker, Susan Valentine, Timothy Hess, Megan Duster and Nasia Safdar

Contemporary clinical trials, Vol.52, pp.39-45

01/01/2017

DOI: 10.1016/j.cct.2016.11.004

PMCID: PMC5670736

PMID: 27836508

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https://www.ncbi.nlm.nih.gov/pmc/articles/5670736View

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Abstract

Staphylococcus aureus (S. aureus) is an organism of great public health importance, causing 20,000 deaths annually. Decolonization of patients with S. aureus may prevent infections, yet current options are limited to antimicrobials that promote antibiotic resistance and can cause adverse side effects. Probiotics have potential to reduce colonization of pathogenic bacteria, representing a promising alternative for S. aureus decolonization, but thus far lack rigorous evaluation. Potential subjects were recruited from inpatient and outpatient settings within a VA medical center and screened for S. aureus gastrointestinal (GI) or extra-GI colonization using swabs at multiple body sites. Positive, eligible, consenting participants were stratified by colonization site and randomized in a 1:1 ratio to 4-weeks of daily placebo or Lactobacillus rhamnosus (L. rhamnosus) HN001 probiotic treatment. Blood and stool samples, and treatment adherence reports were collected from each subject throughout the study, along with a final set of swabs at study completion to detect S. aureus carriage. The outcomes of this study are GI or extra-GI carriage by S. aureus at the end of 4weeks of therapy, change in phagocytic activity of polymorphonuclear cells from pre-intervention to post-intervention, and symptomatic S. aureus infection at any site during the study period. 114 participants have been recruited for this study. Analysis of outcomes is underway. This is the first clinical trial to examine the efficacy of L. rhamnosus HN001 for decolonization of S. aureus, and investigates the mechanism by which L. rhamnosus HN001 mediates its effect on S. aureus colonization. ClinicalTrials.govIdentifier NCT01321606.

Carrier State - drug therapy

Double-Blind Method

Humans

Lactobacillus rhamnosus

Probiotics - therapeutic use

Staphylococcal Infections - drug therapy

Staphylococcus aureus

United States

United States Department of Veterans Affairs

Veterans

Details

Title: Subtitle: Impact of Probiotics for Reducing Infections in Veterans (IMPROVE): Study protocol for a double-blind, randomized controlled trial to reduce carriage of Staphylococcus aureus
Creators: Shoshannah Eggers - University of Wisconsin–Madison
Anna Barker - University of Wisconsin–Madison
Susan Valentine - William S. Middleton Memorial Veterans Hospital
Timothy Hess - University of Wisconsin–Madison
Megan Duster - University of Wisconsin–Madison
Nasia Safdar - UW Health University Hospital
Resource Type: Journal article
Publication Details: Contemporary clinical trials, Vol.52, pp.39-45
DOI: 10.1016/j.cct.2016.11.004
PMID: 27836508
PMCID: PMC5670736
NLM abbreviation: Contemp Clin Trials
ISSN: 1551-7144
eISSN: 1559-2030
Grant note: UL1 TR000427 / NCATS NIH HHS TL1 TR000429 / NCATS NIH HHS T32 GM008692 / NIGMS NIH HHS I01 CX000391 / CSRD VA
Language: English
Date published: 01/01/2017
Academic Unit: Epidemiology; Injury Prevention Research Center
Record Identifier: 9984446405202771

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