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Abstract
Grant Number: 5U01AT001892-03 Project Title: Probiotic Lactobacillus GG to Eliminate VRE Colonization
PI Information: Name Title SNYDMAN, DAVID R. dsnydman@tufts-nemc.org Abstract: DESCRIPTION (provided by applicant): Long term carriage of Vancomycin resistant enterococci (VRE) is becoming a major public health problem in hospitalized patients, in patients in nursing homes, and among immunosuppressed populations. Eradication of this organism from colonized patients is difficult and usually unsuccessful. Patients who become infected with this organism are at risk of significant morbidity and mortality. Based on our preliminary data indicating that a probiotic, Lactobacillus rhamnosus GG (LGG) broth filtrate is bactericidal to VRE in vitro, we propose to conduct a pilot trial to evaluate whether LGG or placebo is effective in the elimination of VRE among those patients already colonized with VRE. The goals of the study are to determine the extent to which LGG will eliminate VRE from the gastrointestinal tract of colonized individuals compared to placebo, to assess the feasibility of the use of the probiotic LGG to colonize the GI tract of patients who are colonized with VRE, and to assess the ability of LGG to be used safely in this patient population. We will enroll 38 patients who are colonized with VRE into a randomized, double blind, placebo controlled pilot trial. Nineteen patients will receive a daily dose of 2 x 1010 of LGG, and 19 will receive an identical appearing placebo, for 14 days. Stools will be collected twice weekly from enrollment through 21 days, and at 28 and 56 days. Stools will be tested both semi-quantitatively and qualitatively for the presence of VRE, Enterococci, and LGG. For the primary analysis, the proportion of patients colonized with VRE at day 21 post randomization will be compared between patients in the LGG and control groups using Fisher's Exact test with a two-sided alpha of 0.05. With the proposed sample size, this study will have a power of 80% to detect a statistically significant difference between groups if the VRE colonization rate in the control group remains high at 90% while the VRE colonization rate in the LGG treated group is reduced to 45% at 3 weeks post randomization. A data safety monitoring board will evaluate study safety throughout the trial. This pilot study will enable us to establish whether the probiotic LGG can affect the colonization of VRE in the gastrointestinal tract of ambulatory patients colonized with VRE, and will be used to design a larger intervention should there be preliminary evidence of effectiveness.
Public Health Relevance:
This Public Health Relevance is not available.Thesaurus Terms:
Enterococcus, Lactobacillus, alternative medicine, biotherapeutic agent, drug screening /evaluation, human therapy evaluation, microorganism disease chemotherapy
bacteria infection mechanism, bacterial disease, communicable disease control, disease /disorder proneness /risk, drug resistance, intestine disorder, microorganism growth, vancomycin, virulence
clinical research, human subject, patient oriented research, placebo
Institution: TUFTS MEDICAL CENTER 800 WASHINGTON ST BOSTON, MA 021111533 Fiscal Year: 2006 Department: Project Start: 15-SEP-2004 Project End: 31-MAY-2009 ICD: NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE IRG: ZAT1