1a.Objectives (from AD-416):
To determine 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. The 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.
Probiotics have shown promise for many applications, especially in areas of gastrointestinal health, such as antibiotic-associated diarrhea. As an alternative to probiotic supplements, yogurt can be an effective delivery method for probiotics but it is not generally formulated with optimal strains or sufficient dosages. A study was designed to determine the safety profile of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) supplemented yogurt when consumed by generally healthy adults who were prescribed a 10-day course of penicillin-class antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to effect the expression of whole blood immune markers associated with cell activation and inflammatory response. A Phase I, double-blinded, randomized, placebo-controlled pilot study was conducted in compliance with United States Food and Drug Administration guidelines for an Investigational New Drug. Forty participants were randomly assigned to consume four ounces of either the active probiotic yogurt supplemented with BB-12 or placebo yogurt daily for 10 days. A daily serving of active product provided no less than 1x10(10) colony forming units per day of BB-12. The primary outcome was assessed by the number of reported adverse events. In total, 40 healthy individuals aged 18-65 years were enrolled in the study. A total of 165 non-serious adverse events were reported, with no significant differences between the control and active yogurt groups. BB-12 supplemented yogurt is safe and well-tolerated when consumed by generally healthy adults concurrently taking antibiotics, and is an effective delivery vehicle for probiotics. This study will form the basis for future, larger randomized clinical trials investigating the effects of BB-12 supplemented yogurt in decreasing illness.