2010 Annual Report 1a.Objectives (from AD-416) To determining the impact of health-promoting components in foods including oral delivery of probiotic bacteria. In-house research demonstrated that Bb12 has a beneficial immune modulating effect on neonatal pigs with improved epithelial and changes in systemic immune markers. On the basis of these results, similar effects are predicted in humans. Our Project Plan has one objective that directly relates to this agreement: To elucidate the mechanisms used by probiotic bacteria to improve respiratory and intestinal mucosal responses to allergens, and correlate intestinal micro-flora composition of pigs and humans with biomarkers of allergic and intestinal disease. The Cooperator is interested in the evaluation of the effects of Bb12 on adults given antibiotics as part of a Phase I study to demonstrate the safety of the strain and improve health outcomes. ARS will acquire nucleic acids from blood and fecal samples from treated subjects to detect specific bacterial genes and patterns of whole blood gene expression as was developed using the pig model. This information will be used by both ARS and the COOPERATOR to jointly develop studies that focus on the effects of Bb12 on the prevention of intestinal disease. 1b.Approach (from AD-416) ARS will acquire nucleic acids from blood and fecal samples from treated subjects to detect specific bacterial genes and patterns of whole blood gene expression as was developed using the pig model. This information will be used by both ARS and the Cooperator to jointly develop studies that focus on the effects of Bb12 on the prevention of intestinal disease. 3.Progress Report The collection of specimens from individuals in the study population has progressed. Analysis of fecal samples for changes in selected bacterial species, including the ingested Bifidobacterium lactis Bb12, and whole blood samples for selected gene expression of immune and inflammatory mediators will commence when all samples have been collected for coordinated assay measurement to reduce technical and experimental error. Activities are monitored by the ARS scientists involved through periodic meetings, email, and conference calls with scientists at Tufts University.