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Experts increasingly advocate aligning safety expectations for high-risk probiotic products (e.g., LBPs) with those applied to other complex biologicals, including systematic genomic characterization, standardized adverse-event reporting, and structured post-market surveillance, while avoiding unnecessarily stricter requirements than for comparable biologic therapies (525)

Halabe 1994

Modeling of the market size and penetration of these drugs varies widely, with estimates of 15 70 million patients by 2028 in different scenarios

Here are the key results from landmark trials that established its clinical credibility

Introduction to the national urology research agenda: A roadmap for priorities in urological disease research