Infant Bacterial Therapeutics AB (publ) (IBT) published clinical findings in the British Journal of Gastroenterology on the convincing association of clinical events to the feeding primary endpoint of the Connection Study. The Connection Study on the pharmaceutical grade probiotic IBP-9414 has two independent primary endpoints- the incidence of Necrotizing Enterocolitis (NEC) and the time to a strict definition of Sustained Feeding Tolerance (SFT). SFT is important to reach as early as possible and a critical goal in the neonatal intensive care (NICU) treatment of premature infants.

Treatment- blind evaluation of the first 641 infants completing the study with use of quantitative statistics revealed significant delays in the time to reach SFT for 23 examined clinical events characteristic of the NICU treatment of premature infants. The greatest delay occurred in infants with gastrointestinal perforation, hypotension, serious cardiac events and pneumonia (mean delays of 10.1-20.0 days). The time to SFT also strongly influenced the duration of NICU stay and was associated with events like NEC, retinopathy of prematurity, late onset sepsis and days on antibiotics for systemic use.

This further builds on the previously published data showing that even a one-day reduction in time to SFT correlates to several clinically meaningful outcomes including reductions in NEC, late onset sepsis, bronchopulmonary dysplasia and antibiotic use.