Send us Fan Mail Probiotics left US NICUs after the FDA reclassified them, and NEC rates went up. This week Ben reviews the Connection Study, a 2,158 infant phase 3 trial of IBP-9414, a live biotherapeutic product containing Limosilactobacillus reuteri, run under an IND with the regulatory rigor probiotics never had. Neither primary endpoint reached significance, but all cause mortality fell 27%, and surgically confirmed NEC favored treatment after 14 days of dosing. The discussion may be the...