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United States Department of Agriculture

Agricultural Research Service

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Research Project: Open Label Study to Evaluate the Safety of Lactobacillus Rhamnosus Gg Atcc 53103 in Healthy Volunteers

Location: Diet, Genomics and Immunology Lab

Project Number: 1235-51000-055-11
Project Type: Reimbursable

Start Date: Dec 15, 2010
End Date: Aug 31, 2014

Objective:
This project will characterize the whole blood response of healthy subjects to LGG using a select panel of cytokine and chemokine markers detected by real time PCR, and a more robust evaluation of transcriptomic changes detected prior to during and after feeding of LGG. Associations will be developed with the levels of LGG, Bifidobacterium and Lactobacillus spp. in the feces and naso-pharynx. The cooperator is interested in detecting LGG and evaluating the clinical effects in healthy adults fed LGG as part of a Phase I study to demonstrate safety strain.

Approach:
ARS will acquire nucleic acids from whole blood PaxGene and fecal samples from treated subjects to detect specific bacterial genes and patterns of whole blood gene expression as was developed in-house using a pig model. The analysis will include Illumina-based deep sequencing of samples from subjects prior to feeding LGG, after 28 days of feeding, and 28 days after cessation of feeding. This information will be used by both ARS and the Cooperator to jointly develop studies that focus on the effects of probiotic bacteria LGG as a vaccine adjuvant. The Cooperator will collate this information with a comprehensive clinical evaluation of the subjects, including routine anaerobic culture – LGG recovery in naso-pharynx and GI tract.

Last Modified: 4/17/2014
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