Probiotics are live microorganisms that, when administered in sufficient doses, provide
health benefits on the host. The United States Food and Drug Administration (FDA) requires
phase I safety studies for probiotics when the intended use of the product is as a drug. The
purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B.
lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy
group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection …

Objectives: Probiotics are live microorganisms that may provide health benefits to the
individual when consumed in sufficient quantities. For studies conducted on health or
disease endpoints on probiotics in the United States, the Food and Administration has
required those studies to be conducted as investigational new drugs. This phase I, double-
blinded, randomized, controlled safety study represents the first requirement of this pathway.
The purpose of the study was to determine the safety of Bifidobacterium animalis subsp …