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CECT5716 Lc40 对母婴生长发育与健康的影响:一项护理产妇的随机临床试验。

Effects of CECT5716 Lc40 on infant growth and health: a randomised clinical trial in nursing women.

机构信息

Biosearch Life SA, Camino de Purchil 66, 18004 Granada, Spain.

LMU - Ludwig-Maximilians-Universität München, Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, University of Munich Medical Centre, Lindwurmstrasse 4, 80337 Munich, Germany.

出版信息

Benef Microbes. 2020 May 11;11(3):235-244. doi: 10.3920/BM2019.0180. Epub 2020 Mar 27.

DOI:10.3920/BM2019.0180
PMID:32216468
Abstract

The breast milk microbiota has been described as a source of bacteria for infant gut colonisation. We studied the effect of CECT5716 (Lc40) on growth and infection incidence of the infants, when the probiotic is administrated to the mothers. Moreover, whether such effects might depend on the interaction between the mother or infant microbiota and the probiotic administration. A total of 291 mother-infant pairs were studied for 16 weeks in a randomised double-blinded placebo-controlled multicentre trial. The Lc40 group (n=139) received 1 capsule/day containing 3×10 cfu Lc40; the control group (n=152) received 1 placebo (maltodextrin) capsule/day. A positive and significant correlation of the load between breast milk and infant faeces was only observed in control group. Additionally, the weight z-score of the infants whose mothers had higher values of in their breast milk were significantly higher for the Lc40 group. We observed a significant lower incidence of conjunctivitis in the infants whose mothers received Lc40. A higher load of in infant faeces significantly increased the risk of respiratory infections. Such incidence, under an absent or low load in the faeces, was significantly 36 times higher in the infants in the control group than in the infants in the Lc40 group. However, the protective effect of Lc40 was gradually reduced as the load of the milk increased. The administration of Lc40 to nursing women might influence infant growth and health but it seems to depend on its interactions with mother or infant microbiota. Registered in the US Library of Medicine (www.clinicaltrials.gov): NCT02203877.

摘要

母乳微生物群被描述为婴儿肠道定植的细菌来源。我们研究了当益生菌被给予母亲时,CECT5716(Lc40)对婴儿生长和感染发生率的影响。此外,这种影响是否可能取决于母亲或婴儿的微生物群与益生菌的给药之间的相互作用。在一项随机、双盲、安慰剂对照的多中心试验中,对 291 对母婴进行了 16 周的研究。Lc40 组(n=139)每天服用 1 粒含有 3×10 cfu Lc40 的胶囊;对照组(n=152)每天服用 1 粒安慰剂(麦芽糊精)胶囊。仅在对照组中观察到母乳和婴儿粪便之间的负荷呈正相关且显著。此外,母亲母乳中 值较高的婴儿的体重 z 评分显著更高。我们观察到接受 Lc40 的母亲的婴儿结膜炎发病率显著降低。婴儿粪便中 值较高的婴儿患呼吸道感染的风险显著增加。在对照组中,当粪便中 值较低或不存在时,这种发病率显著增加了 36 倍,而在 Lc40 组中,婴儿的发病率显著降低。然而,随着牛奶中 值的增加,Lc40 的保护作用逐渐减弱。给予哺乳期妇女 Lc40 可能会影响婴儿的生长和健康,但似乎取决于它与母亲或婴儿微生物群的相互作用。在美国医学图书馆注册(www.clinicaltrials.gov):NCT02203877。

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