关于早产婴儿发病率的L.Fermentum CECT5716和B.Breve CECT7263:一个随机临床试验

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Probiotic Studies in Neonatal Mice Using Gavage

Probiotic Studies in Neonatal Mice Using Gavage

Published on: January 27, 2019

José Antonio Hurtado Suazo¹, Almudena Alonso Ojembarrena^2,3, Tomás Sánchez Tamayo⁴

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

Pediatric research

|November 27, 2025

概括

这项研究发现,在早产婴儿中,高剂量和低剂量益生菌之间的死亡率或死性肠球炎 (NEC) 没有显著差异. 这些益生菌的低剂量可能足够,支持它们的安全性和耐受性.

科学领域:

新生儿医学新生儿医学
微生物学微生物学
胃肠病学胃肠病学

背景情况:

结核性肠球炎 (NEC) 和死亡率是早产婴儿的重大问题.
关于益生菌对早产婴儿的有效性和最佳剂量的证据仍然有限.
这项研究解决了对这种脆弱人群中益生菌安全性和益处的更多临床试验的需求.

研究的目的:

评估两种不同剂量的特定益生菌组合对非常低出生体重早产新生儿NEC发病率和死亡率的影响.
评估这些益生菌剂量在早产婴儿中的安全性和耐受性.
将结果与区域队列进行比较,以对发现进行背景化.

主要方法:

一项多中心,随机,双盲研究,涉及583名早产新生儿 (≤32 6/7周,<1500g).
婴儿接受了Limosilactobacillus fermentum CECT5716 (LC40) 和Bifidobacterium breve CECT7263 (BfM26) 的高剂量 (HD) 或低剂量 (LD).
益生菌被管理到36 6/7周的月经后年龄或排泄,结果包括NEC和死亡率跟踪.

主要成果:

益生菌组合耐受性良好,没有报告的不良反应.
在HD和LD组之间没有观察到NEC率 (2.5%对1.3%) 或死亡率 (3.9%对3.6%) 的显著差异.
在这项研究中,NEC的发病率和死亡率低于同期SEN1500队列中报告的.

结论:

高剂量和低剂量的LC40和BfM26益生菌组合在早产婴儿中显示出类似的安全性和耐受性.
这种益生菌组合的低剂量可能足以给予益处,可能减少NEC和死亡率.
研究结果支持这些益生菌的安全性,并表明较低剂量可能是有效的,指导未来研究最佳益生菌在早产新生儿的管理.

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