Open Label Study to Evaluate the Safety of Lactobacillus Rhamnosus Gg Atcc 53103 in Healthy Volunteers
Diet, Genomics and Immunology Lab
2011 Annual Report
1a.Objectives (from AD-416)
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.
1b.Approach (from AD-416)
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.
To establish safety and tolerability of Lactobacillus rhamnossus (LGG) ATCC 53103, 50 adult patients at Massachusetts General Hospital will receive a daily oral dose of LGG for 6 months. Assessment of safety will be determined by medical examination and measurement of pro-inflammatory gene biomarkers in peripheral blood cells and colonization of LGG in the gastrointestinal tract at different times after feeding. Subjects are currently being recruited for the project and samples have been archived from those already treated so that all samples can be evaluated at one time. This agreement was monitored through email and telephone communication.