IBP-9414 / BioGaia - LARVOL DELTA

EFFECTS OF IBP-9414, A LIVE BIOTHERAPEUTIC PRODUCT, ON NECROTIZING ENTEROCOLITIS, FULL ENTERAL FEEDING, AND MORTALITY IN VERY LOW BIRTH WEIGHT INFANTS: CONNECTION STUDY RESULTS (ESPGHAN 2025) - "Conclusions IBP-9414 treatment was associated with significant reduction in all-cause mortality. The efficacy findings coupled with a favorable safety profile support a positive benefit-risk profile for IBP- 9414 in VLBW infants."

Gastrointestinal Disorder

IBP-9414, A LIVE BIOTHERAPEUTIC PRODUCT, REDUCE ALL-CAUSE MORTALITY IN VERY LOW BIRTHWEIGHT INFANTS: RESULTS FROM THE 'CONNECTION STUDY' (ESPGHAN 2025) - P3 | "Conclusions Treatment with IBP-9414 compared to placebo was associated with reduced overall mortality, which related to local actions of L. reuteri on the gut and systemic actions of a possibly anti-inflammatory character. These findings together with the absence of safety concerns show a positive benefit: risk ratio for IBP-9414 on mortality in VLBW infants."

Infectious Disease • Septic Shock

EFFECT OF IBP-9414, A LIVE BIOTHERAPEUTIC PRODUCT ON NECROTIZING ENTEROCOLITIS IN VERY LOW BIRTH WEIGHT INFANTS: RESULTS FROM THE 'CONNECTION STUDY' (ESPGHAN 2025) - No abstract available

Gastrointestinal Disorder

EFFECT OF IBP-9414 ON TIME TO A STRICT DEFINITION OF SUSTAINED, FULL ENTERAL FEEDING IN VERY LOW BIRTH WEIGHT INFANTS: RESULTS FROM THE 'CONNECTION STUDY' (ESPGHAN 2025) - No abstract available

Effect of IBP-9414 vs placebo on time to reach sustained full enteral feeding in very low birth weight (VLBW) infants: Results from the “Connection Study” (PAS 2025) - P3 | "Median birth weight, gestational age at birth, and length of treatment were 850 g, 27 weeks, and 50 days, respectively. SFT was reached by 75% of IBP-9414 treated infants and 71% of those receiving placebo and the median time to SFT was not statistically different but numerically shorter (21 days vs. 23 days) in the IBP-9414 group (p=0.07, Fig."

Clinical

Effects of IBP-9414, a Live Biotherapeutic Product on necrotizing enterocolitis, time to full enteral feeding, and mortality in very low birth weight infants: Results from the “Connection Study (PAS 2025) - No abstract available

Gastrointestinal Disorder

Clinical Characteristics of Necrotizing Enterocolitis Diagnosed by Independent Adjudication of Abdominal Radiographs, Laparotomy, or Autopsy in Preterm Infants in the "Connection Trial". (PubMed, Am J Perinatol) - "· Independent adjudication of abdominal radiographs in ELBW infants increased NEC recognition. · Risk of NEC decreased by 11 to 30% with every 100-g increment in BW and GA week. · In infants with BW 750 to 1,000 g, the risk of death from NEC was almost twice that in infants with BW 500 to 749 g. · Infants with NEC received antibiotics during one-third and parenteral nutrition during half of the first 7 postnatal weeks."

Clinical • Journal • Cardiovascular • Diabetes • Gastrointestinal Disorder • Heart Failure • Hypotension • Infectious Disease • Renal Disease • Septic Shock

Diverse Enteral Feeding Practices in Contemporary ELBW Infants in the Connection Trial (PAS 2024) - P3 | "It compares the potential new biological entity IBP-9414 (L... Kaplan-Meier estimates of total enteral feeding volumes showed that >10mL/kg/day was reached at median 2 to 11 days and the more composite endpoint of SFT at median 9 to 84 days of age (Fig. 1). Any mother’s milk was given during median 95% (IQR 85-100%, range 0-100%) and parenteral nutrition during 33% (IQR18-60%, range 0-100%) of the study days."

Infectious Disease • Septic Shock

IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study (clinicaltrials.gov) - P3 | N=2158 | Active, not recruiting | Sponsor: Infant Bacterial Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Jul 2024 | Trial primary completion date: Nov 2023 ➔ Jun 2024

Enrollment closed • Trial completion date • Trial primary completion date • Gastrointestinal Disorder