Shoshannah Eggers1, Anna Barker2, Susan Valentine3, Timothy Hess4, Megan Duster5, Nasia Safdar6. 1. William S. Middleton Memorial Veterans Affairs Medical Center, Department of Medicine, Madison, WI, USA; University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA; Department of Population Health Sciences, University of Wisconsin - Madison School of Medicine and Public Health, Madison, WI, USA. 2. Department of Population Health Sciences, University of Wisconsin - Madison School of Medicine and Public Health, Madison, WI, USA. 3. William S. Middleton Memorial Veterans Affairs Medical Center, Department of Medicine, Madison, WI, USA. 4. William S. Middleton Memorial Veterans Affairs Medical Center, Department of Medicine, Madison, WI, USA; University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA. 5. University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA. 6. William S. Middleton Memorial Veterans Affairs Medical Center, Department of Medicine, Madison, WI, USA; Department of Population Health Sciences, University of Wisconsin - Madison School of Medicine and Public Health, Madison, WI, USA; University of Wisconsin Hospitals and Clinics, Madison, WI, USA. Electronic address: nasia.safdar@va.gov.
Abstract
BACKGROUND: 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. METHODS: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. CONCLUSION: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. Published by Elsevier Inc.
RCT Entities:
BACKGROUND: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. METHODS: 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. CONCLUSION: 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. Published by Elsevier Inc.
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