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

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 4 weeks 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.

Effect of Lactobacillus rhamnosus HN001 on carriage of Staphylococcus aureus: results of the impact of probiotics for reducing infections in veterans (IMPROVE) study

“…The full protocol for this study has been previously published [ 24 ]. Study procedures and written consent form were approved by the University of Wisconsin Institutional Review Board and the Veterans Affairs Research and Development Committee.…”

“…A variety of exclusion criteria were used, including current MRSA decolonization or treatment regimens. A full list of inclusion and exclusion criteria are listed in the protocol [ 24 ].…”

The Role of Probiotics and Synbiotics on Hirsutism

“…The term probiotic was introduced by Werner Kollath [13] and according to the World Health Organisation (WHO), this term refers to the microorganisms that ''when administered in adequate amounts, confer a health benefit on the host" [14]. Probiotics are found to have multiple beneficial roles on human health and disease, through restoration of gut microbiota (GM) [15,16], symptom improvement on intestinal disease, such as irritable bowel syndrome (IBS) [17], modulation of hormonal profile in animals and humans [18][19][20][21][22] and skin infections and healing [23][24][25]. Along with the beneficial microorganisms, prebiotics, which are fermented compounds that support and promote modifications in the activity and composition of GM [26], have also been studied.…”

Isolation and Molecular Identification of Potential Probiotic Yeast Strains Found in Malaysian Kefir Drinks Samples

“…In the recent years, the use of a probiotic product containing beneficial strain is not only for gastrointestinal disease treatment but also for the overall human health in medicine and dentistry. A considerable amount of literature has been published on the therapeutic potential and health benefit of probiotics such as the prevention of diarrheal disease [6], colon cancer [7], and upper GI tract disease [8], and to improve the immune system against intestinal infections [9].…”