2012 Annual Report 1a.Objectives (from AD-416): Enhance communication and interaction between the ARS/BHNRC and the NIH's National Center for Complementary and Alternative Medicine reseach communities to facilitate research on probiotics in human subjects, and to integrate results from that research into an improved understanding of the mechanism of action of probiotics and their effects on human health. 1b.Approach (from AD-416): Each Agency has existing programs and resources for facilitating reearch and technology development. Research facilitated by this MOU will be complementary to studies supported by the ARS/BHNRC and NIH/NCCAM at the agencies' intramural and extramural laboratories. 3.Progress Report: During FY2012, clinical samples from healthy adults and elderly subjects from a Phase I one year longitudinal study and an open label study consuming probiotic strain Lactobacillus rhamnosus were received and processed. These clinical studies were conducted at Massachusetts General Hospital and funded through a supplementary project through NIH/NCCAM. The ongoing analysis by transcriptome sequencing will identify biomarkers in whole blood associated with probiotic consumption and modulation of immune response for assessing safety. Changes in microbiota composition of treated subjects have been evaluated.