Episode Details
Back to Episodes#458 - [Journal Club] - đź“Ś Is this the trial that brings probiotics back to the NICU?
Description
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 real story, including a kappa of 0.36 between radiologists reading the same NEC films. Ben and Daphna talk through what a regulated probiotic would mean for the babies waiting now.
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Live biotherapeutic product IBP-9414 (L. reuteri) in very low birth weight infants: the Connection Study. Neu J, Del Moral T, Guthrie SO, Hudak ML, Indrio F, Kim JH, Kronström A, Martin CR, Modi N, Rastad J, Schnitzer TJ, Singh R, Strömberg S, Szajewska H, Thuresson M, Caplan M.Pediatr Res. 2026 Feb 20. doi: 10.1038/s41390-026-04826-7. Online ahead of print.PMID: 41721054
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