Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2017 Jan:52:39-45.
doi: 10.1016/j.cct.2016.11.004. Epub 2016 Nov 9.

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  1 , Anna Barker  2 , Susan Valentine  3 , Timothy Hess  4 , Megan Duster  5 , Nasia Safdar  6
Affiliations
Clinical Trial

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 et al. Contemp Clin Trials. 2017 Jan.

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.

Keywords: Clinical trial; Lactobacilli; MRSA; Probiotics; Staphylococcus aureus; Veterans.

PubMed Disclaimer

Conflict of interest statement

Competing interests

The authors have no conflict of interest to disclose.

Figures

Fig. 1
Fig. 1
Schematic representation of the IMPROVE protocol.
See this image and copyright information in PMC

References

    1. Klevens R, Morrison MA, Nadle J, et al. Invasive methicillin-resistant staphylococcus aureus infections in the United States. JAMA. 2007;298(15):1763–1771. http://dx.doi.org/10.1001/jama.298.15.1763. - DOI - PubMed
    1. P R V, J M. A comparative analysis of community acquired and hospital acquired methicillin resistant Staphylococcus aureus. J Clin Diagn Res JCDR. 2013;7(7):1339–1342. http://dx.doi.org/10.7860/JCDR/2013/5302.3139. - DOI - PMC - PubMed
    1. Huang H, Flynn NM, King JH, Monchaud C, Morita M, Cohen SH. Comparisons of community-associated methicillin-resistant Staphylococcus aureus (MRSA) and hospital-associated MSRA infections in Sacramento, California. J Clin Microbiol. 2006;44(7):2423–2427. http://dx.doi.org/10.1128/JCM.00254-06. - DOI - PMC - PubMed
    1. Malani PN. National burden of invasive methicillin-resistant staphylococcus aureus infection. JAMA. 2014;311(14):1438–1439. http://dx.doi.org/10.1001/jama.2014.1666. - DOI - PubMed
    1. Perl TM, Cullen JJ, Wenzel RP, et al. Intranasal mupirocin to prevent postoperative Staphylococcus aureus infections. N. Engl. J. Med. 2002;346(24):1871–1877. http://dx.doi.org/10.1056/NEJMoa003069. - DOI - PubMed

Publication types

Associated data