Live biotherapeutic product IBP-9414 (L. reuteri) in very low birth weight infants: the Connection Study.
Academic Article
Overview
abstract
BACKGROUND: Very low birth weight (VLBW) infants experience high rates of serious intestinal health outcomes, including death. The Connection Study evaluated the efficacy and safety of the live biotherapeutic product IBP-9414 (L. reuteri) versus placebo in necrotizing enterocolitis (NEC), sustained feeding tolerance (SFT), and all-cause mortality in this population. METHODS: In this prospective, double-blind phase 3 trial, 2158 VLBW infants were randomized 1:1 to IBP-9414 or placebo within 48 hours of birth, with daily dosing until 346/7 weeks postmenstrual age. Primary endpoints were NEC incidence and time to SFT. Secondary endpoints included all-cause mortality incidence. RESULTS: IBP-9414 treatment compared with placebo did not result in statistically significant reductions in the primary endpoints, NEC incidence (relative risk [RR]: 0.85, p > 0.05) or time to SFT (hazard ratio: 1.10, p > 0.05). However, there was a reduction in all-cause mortality with IBP-9414 treatment, with mortality incidences of 6.2% in the IBP-9414 group versus 8.5% in the placebo group (RR: 0.73, p = 0.036). Adverse event rates were similar between the groups. There was no evidence of IBP-9414 in any blood culture. CONCLUSIONS: IBP-9414 treatment was safe and reduced mortality compared with placebo in vulnerable VLBW infants. IMPACT: The Connection Study provides evidence that the live biotherapeutic product IBP-9414 (L. reuteri) treatment was safe and reduced both mortality and surgically-confirmed necrotizing enterocolitis (NEC) in vulnerable very low birth weight (VLBW) infants. The Connection Study findings support the use of IBP-9414 in VLBW infants and its potential to safely improve their intestinal mortality and morbidity.
