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Abstract

Grant Number:	5U01AT002133-02
Project Title:	Probiotics to Eradicate Nasal S Aureus in ESRD Patients

PI Information:	Name	Email	Title
	HIBBERD, PATRICIA L.	patricia.hibberd@tufts.edu	PROFESSOR OF MEDICINE & PEDIATRICS

Abstract: DESCRIPTION (provided by applicant): Emergence of antimicrobial resistance is an ever-increasing threat to our ability to treat a wide range of infections caused by microbes that thwart or block antimicrobial therapy. Staphylococcus aureus, an organism that is frequently found to be resistant to multiple antibiotics, is a major and increasing cause of morbidity and mortality in patients on chronic dialysis. Since nasal carriage of Staphylococcus aureus generally precedes infection and is a well established risk factor for invasive disease, eradication of this organism from the nares is of major clinical importance. Current strategies, particularly those that use antibiotics, often lead to antimicrobial resistance, side effects and relapse. Probiotics, particularly Lactobacillus GG (LGG) are capable of killing various bacteria, including Staphylococcus aureus, in vitro, by a variety of mechanisms. Preliminary data from one small study in healthy volunteers suggests that LGG may be able to eradicate nasal carriage of S aureus. We propose to conduct a pilot double-blind randomized placebo controlled clinical trial to refine methodology and determine the feasibility of evaluating whether LGG administered orally or topically is effective in eliminating nasal colonization with Staphylococcus aureus in patients on chronic hemodialysis. If safe and effective, LGG may provide an alternative way to eliminate this bacteria without use of antimicrobials that risk emergence of resistance. Fifty patients on hemodialysis will be recruited into the study, 20 will receive oral LGG, 20 will receive topical LGG and 10 will receive oral and topical placebo. The specific aims are to: (1) refine and test feasibility of administering oral and topical probiotics and matching placebo, in preparation for future studies that will investigate the effect of probiotics on eradication of nasal carriage of Staphylococcus aureus; (2) collect pilot data on limination of nasal colonization with Staphyloccous aureus to power future studies that will evaluate whether LGG is an effective alternative to antimicrobials; and (3) determine whether LGG colonizes the nares as a first step to exploring potential mechanisms by which LGG may influence mucosal Staphylococcus aureus colonization. This study has the potential to provide insight into a novel alternative approach to eradicate and prevent the spread of antimicrobial resistant pathogens.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
Lactobacillus, Staphylococcus aureus, biotherapeutic agent, human therapy evaluation, oral administration, topical drug application
clinical trial, communicable disease transmission, disease /disorder proneness /risk, hemodialysis, multidrug resistance
clinical research, human subject, patient oriented research

Institution:	TUFTS MEDICAL CENTER
	800 WASHINGTON ST
	BOSTON, MA 021111533
Fiscal Year:	2005
Department:
Project Start:	15-JUN-2004
Project End:	31-MAY-2009
ICD:	NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE
IRG:	ZAT1

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