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Background <p>This study examined the effects of two doses of probiotics isolated from human milk on the incidences of necrotizing enterocolitis (NEC) and mortality in preterm infants.</p> Methods <p>This multicenter, randomized, double-blind study involved 583 very low birth weight preterm neonates (≤32 6/7 weeks, &lt;1500 g) who started enteral nutrition within 72 h of birth (&gt;5 ml/kg/day) and received either a high-dose (HD, 1 × 10<sup>9</sup> CFU/day per strain) or a low-dose (LD, 1 × 10<sup>6</sup> CFU/day per strain) of <i>Limosilactobacillus fermentum</i> CECT5716 (LC40) and <i>Bifidobacterium breve</i> CECT7263 (BfM26) until 36 6/7 weeks postmenstrual age or discharge.</p> Results <p>The probiotic combination was well tolerated with no adverse effects. The NEC (2.5% vs. 1.3%; <i>p</i> = 0.156) and mortality (3.9% vs. 3.6%; <i>p</i> = 0.685) rates were not significantly different between the groups (HD vs. LD). These rates were lower than those reported in a co-temporal cohort in the region (SEN1500 cohort).</p> Conclusion <p>No significant differences were found between the HD and the LD of the LC40 and BfM26 combination in the incidence of NEC and all-cause mortality. The incidence rates of death and NEC were lower in this study than in the SEN1500 cohort, suggesting that the&#xa0;low dose may suffice for preterm infants. This study supports the safety and tolerability of these probiotics in preterm infants.</p> Impact <p><UnorderedList Mark="Bullet"> <ItemContent> <p>The study responds to scientific societies’ request for more clinical trials to strengthen the currently low level of evidence on probiotics’ safety and benefits for preterm infants.</p> </ItemContent> <ItemContent> <p>The study presents evidence supporting the safety and the effect of two different doses of a combination of two human milk-derived probiotic strains in preterm infants.</p> </ItemContent> <ItemContent> <p>The study indicates that a low dose of probiotics may be sufficient to achieve beneficial effects in preterm infants. These findings will inform future research on optimizing probiotic dosing in this population.</p> </ItemContent> </UnorderedList></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月27日

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  • José Antonio Hurtado Suazo,
  • Almudena Alonso Ojembarrena,
  • Tomás Sánchez Tamayo,
  • Estefania Martín Alvarez,
  • Maria Eugenia Saez,
  • Luz Martínez Pardo,
  • Javier Díez Delgado Rubio,
  • Mercedes Granero Asencio,
  • Laura Serrano López,
  • Jose Antonio Maldonado-Lobón,
  • David Mora Navarro,
  • María Teresa de Benito Guerra,
  • Eva Torres Begara,
  • Juan Antonio Ruiz Moreno,
  • Carmen Macías Díaz,
  • José María Lloreda García,
  • Manuela Peña Caballero,
  • Mónica Olivares,
  • Ruth Blanco-Rojo

摘要

Background

This study examined the effects of two doses of probiotics isolated from human milk on the incidences of necrotizing enterocolitis (NEC) and mortality in preterm infants.

Methods

This multicenter, randomized, double-blind study involved 583 very low birth weight preterm neonates (≤32 6/7 weeks, <1500 g) who started enteral nutrition within 72 h of birth (>5 ml/kg/day) and received either a high-dose (HD, 1 × 109 CFU/day per strain) or a low-dose (LD, 1 × 106 CFU/day per strain) of Limosilactobacillus fermentum CECT5716 (LC40) and Bifidobacterium breve CECT7263 (BfM26) until 36 6/7 weeks postmenstrual age or discharge.

Results

The probiotic combination was well tolerated with no adverse effects. The NEC (2.5% vs. 1.3%; p = 0.156) and mortality (3.9% vs. 3.6%; p = 0.685) rates were not significantly different between the groups (HD vs. LD). These rates were lower than those reported in a co-temporal cohort in the region (SEN1500 cohort).

Conclusion

No significant differences were found between the HD and the LD of the LC40 and BfM26 combination in the incidence of NEC and all-cause mortality. The incidence rates of death and NEC were lower in this study than in the SEN1500 cohort, suggesting that the low dose may suffice for preterm infants. This study supports the safety and tolerability of these probiotics in preterm infants.

Impact

The study responds to scientific societies’ request for more clinical trials to strengthen the currently low level of evidence on probiotics’ safety and benefits for preterm infants.

The study presents evidence supporting the safety and the effect of two different doses of a combination of two human milk-derived probiotic strains in preterm infants.

The study indicates that a low dose of probiotics may be sufficient to achieve beneficial effects in preterm infants. These findings will inform future research on optimizing probiotic dosing in this population.