Link to dataset related to article "Analysis of immune, microbiota and metabolome maturation in infants in a clinical trial of Lactobacillus paracasei CBA L74-fermented formula"

This record contains raw data related to article “Analysis of immune, microbiota and metabolome maturation in infants in a clinical trial of Lactobacillus paracasei CBA L74-fermented formula"

Mother's milk is the best choice for infants nutrition, however when it is not available or insufficient to satisfy the needs of the infant, formula is proposed as an effective substitute. Here, we report the results of a randomized controlled clinical trial (NCT03637894) designed to evaluate the effects of two different dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula) versus breastfeeding (reference group) on immune defense mechanisms (primary endpoint: secretory IgA, antimicrobial peptides), the microbiota and its metabolome (secondary outcomes), in healthy full term infants according to the type of delivery (n = 13/group). We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk. Metabolome analysis allowed us to distinguish subjects based on their dietary regimen and mode of delivery. Together, these results suggest that a fermented formula favors the maturation of the immune system, microbiota and metabolome.

本数据集收录与学术论文《副干酪乳杆菌（Lactobacillus paracasei）CBA L74发酵配方奶粉临床试验中婴儿免疫、菌群与代谢组成熟度分析》相关的原始实验数据。

母乳是婴儿营养的最优选择，当母乳无法获取或分泌不足、无法满足婴儿营养需求时，配方奶粉可作为有效的替代方案。本研究报道了一项编号为NCT03637894的随机对照临床试验（randomized controlled clinical trial）结果，该试验旨在评估两种不同喂养方案（普通配方奶粉与副干酪乳杆菌CBA L74发酵配方奶粉）相较于母乳喂养（参照组）对健康足月婴儿免疫防御机制的影响，其中主要终点指标为分泌型免疫球蛋白A（secretory IgA）与抗菌肽（antimicrobial peptides），次要结局指标为菌群及其代谢组；试验按分娩方式分组，每组纳入13名婴儿。研究结果表明，该发酵配方奶粉安全性良好、耐受性佳，可提升婴儿分泌型免疫球蛋白A水平（但对抗菌肽无显著影响），并能降低菌群多样性，其效果与母乳喂养相似，但程度稍弱。代谢组分析可根据受试婴儿的喂养方案与分娩方式对其进行区分。综合上述结果可知，副干酪乳杆菌CBA L74发酵配方奶粉可促进婴儿免疫系统、菌群与代谢组的成熟。