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L.Fermentum CECT5716 and B.Breve CECT7263 on premature infants morbidities: a randomized clinical trial

José Antonio Hurtado Suazo1, Almudena Alonso Ojembarrena2,3, Tomás Sánchez Tamayo4

  • 1Neonatology Division, Virgen de las Nieves University Hospital, Granada, Spain. jant.hurtado.sspa@juntadeandalucia.es.

Pediatric Research
|November 27, 2025
PubMed

Insights

This study found no significant difference in necrotizing enterocolitis (NEC) or mortality rates between high- and low-dose probiotics in preterm infants. A low dose of these probiotics may be sufficient, supporting their safety and tolerability.

Area of Science:

  • Neonatal Medicine
  • Microbiology
  • Gastroenterology

Background:

  • Necrotizing enterocolitis (NEC) and mortality are significant concerns in preterm infants.
  • Evidence on the efficacy and optimal dosing of probiotics for preterm infants remains limited.
  • This study addresses the need for more clinical trials on probiotic safety and benefits in this vulnerable population.

Purpose of the Study:

  • To evaluate the effects of two different doses of a specific probiotic combination on NEC incidence and mortality in very low birth weight preterm neonates.
  • To assess the safety and tolerability of these probiotic doses in preterm infants.
  • To compare the outcomes with a regional cohort to contextualize the findings.

Main Methods:

  • A multicenter, randomized, double-blind study involving 583 preterm neonates (≤32 6/7 weeks, <1500g).
  • Infants received either a high-dose (HD) or low-dose (LD) of Limosilactobacillus fermentum CECT5716 (LC40) and Bifidobacterium breve CECT7263 (BfM26).
  • Probiotics were administered until 36 6/7 weeks postmenstrual age or discharge, with outcomes including NEC and mortality tracked.

Main Results:

  • The probiotic combination was well-tolerated with no reported adverse effects.
  • No significant differences in NEC rates (2.5% vs. 1.3%) or mortality rates (3.9% vs. 3.6%) were observed between the HD and LD groups.
  • Incidence rates of NEC and mortality in this study were lower than those reported in the contemporaneous SEN1500 cohort.

Conclusions:

  • A high dose and a low dose of the LC40 and BfM26 probiotic combination demonstrated similar safety and tolerability profiles in preterm infants.
  • The low dose of this probiotic combination may be sufficient to confer benefits, potentially reducing NEC and mortality.
  • Findings support the safety of these probiotics and suggest that lower doses might be effective, guiding future research on optimal probiotic administration in preterm neonates.
Abstract

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