Lactobacillus fermentum CECT 5716 is safe and well tolerated in infants of 1-6 months of age: A Randomized Controlled Trial
Lactobacillus fermentum CECT 5716 is safe and well tolerated in infants of 1-6 months of age: A Randomized Controlled Trial
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DOI：
10.1016/j.phrs.2011.11.016
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发表时间：
2012-02-01
影响因子：
9.3
通讯作者：
Olivares, Monica
中科院分区：
文献类型：
--
作者：
Gil-Campos, Mercedes;Lopez, Miguel Angel;Olivares, Monica
该研究的目的是评估添加发酵乳杆菌CECT5716（一种从母乳中分离的益生菌菌株）的婴儿配方奶粉在1-6月龄婴儿中的安全性和耐受性。对健康婴儿进行随机双盲对照研究。1月龄婴儿连续5个月服用添加发酵乳杆菌的益生元婴儿配方奶粉（试验组）或不添加益生菌菌株的相同配方奶粉（对照组）。该研究的主要结果是基线至4个月大之间的平均每日体重增加。次要结果是其他人体测量数据（长度和头围）、配方奶粉消耗量和耐受性。儿科医生也记录了感染的发生率。在4月龄（29.0 +/- 7.8 vs 28.9 +/- 5.7 g/天）和6月龄（25.1 +/- 6.1 vs 24.7 +/- 5.2 g/天）时，两组之间的体重增加均无显著差异。在配方的消耗量或与配方耐受性相关的症状方面没有统计学上的显著差异。对照组婴儿胃肠道感染发生率是益生菌组的3倍（p = 0.018）。因此，1至6个月食用富含人乳益生菌菌株L发酵CECT5716的益生元婴儿配方奶粉是耐受性良好且安全的。此外，食用这种配方奶粉可以通过减少胃肠道感染的发生率来改善婴儿的健康。(C) 2011 Elsevier Ltd.版权所有。
The objective of the study was to evaluate the safety and tolerance of an infant formula supplemented with Lactobacillus fermentum CECT5716, a probiotic strain isolated from breast milk, in infants of 1-6 months of age. A randomized double blinded controlled study including healthy infants was conducted. One month aged infants received a prebiotic infant formula supplemented with L. fermentum (experimental group) or the same formula without the probiotic strain (control group) for 5 months. The primary outcome of the study was average daily weight gain between baseline and 4 months of age. Secondary outcomes were other anthropometric data (length and head circumference), formula consumption, and tolerance. Incidence of infections was also recorded by pediatricians.No significant differences in weight gain were observed between both groups, neither at 4 months of age (29.0 +/- 7.8 vs 28.9 +/- 5.7 g/day) nor at 6 months (25.1 +/- 6.1 vs 24.7 +/- 5.2 g/day). There were no statistically significant differences in the consumption of the formulae or symptoms related to the tolerance of the formula. The incidence rate of gastrointestinal infections in infants of the control group was 3 times higher than in the probiotic group (p = 0.018).Therefore, consumption of a prebiotic infant formula enriched with the human milk probiotic strain L fermentum CECT5716 from 1 to 6 months of life is well tolerated and safe. Furthermore, the consumption of this formula may improve the health of the infants by reducing the incidence of gastrointestinal infections. (C) 2011 Elsevier Ltd. All rights reserved.