含有六种人乳寡糖、LMG11588和CNCM I-3446的部分水解乳清基婴儿配方奶粉安全、耐受性良好且能改善肠道健康：一项随机试验的阶段性分析
Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, LMG11588, and CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trial.
作者信息
Picaud Jean-Charles, Claris Olivier, Gil-Campos Mercedes, De La Cueva Ignacio Salamanca, Cornette Luc, Alliet Philippe, Léké André, Castanet Mireille, Piloquet Hugues, de Halleux Virginie, Mitanchez Delphine, Vandenplas Yvan, Maton Pierre, Jochum Frank, Olbertz Dirk, Policarpo Sergio Negre, Lavalle Luca, Fumero Cecilia, Rodriguez-Garcia Paula, Moll Janne Marie, Silva-Zolezzi Irma, Zemrani Boutaina, Hays Nicholas P, Sprenger Norbert, Miranda-Mallea Javier
机构信息
Department of Neonatology, Hôpital de La Croix-Rousse, Lyon, France.
CarMen Laboratory, INSERM, INRA, Université Claude Bernard Lyon 1, Pierre-Bénite, Lyon, France.
出版信息
Front Nutr. 2025 Jul 23;12:1628847. doi: 10.3389/fnut.2025.1628847. eCollection 2025.
BACKGROUND AND AIMS
Gut health and microbiome development are closely linked in early life, with human milk oligosaccharides (HMOs) playing a key role. This study reports results through 4 months of age from a trial evaluating an infant formula containing a synbiotic blend of HMOs and probiotics, focusing on growth, gastrointestinal (GI) tolerance, and gut health biomarkers from birth to 15 months.
MATERIALS AND METHODS
Healthy infants aged ≤14 days were randomized to receive either the experimental formula (SYN; control formula supplemented with six HMOs and two probiotics [, ]) or the control formula (CTRL; partially hydrolyzed 100% whey-based formula). A non-randomized breastfed (BF) group served as a reference. The primary endpoint was weight gain velocity in SYN vs. CTRL through 4 months of age. Secondary endpoints included fecal outcomes (abundance of bifidobacteria, immune and gut health markers), GI tolerance, and adverse events (AEs).
RESULTS
The full analysis set (FAS) included 313 infants (118 in SYN, 114 in CTRL, and 81 BF), while the per-protocol population (PP) included 227 infants (84 in SYN, 84 in CTRL, and 59 BF). Weight gain velocity through 4 months in the SYN group was non-inferior to that in the CTRL group in both FAS and PP analyses (both < 0.0001). Parent-reported GI tolerance and stool patterns were similar between SYN and CTRL groups through 4 months. At 3 months, abundance was significantly higher in the SYN group compared to the CTRL group ( = 0.004). Fecal pH was lower in the SYN group than in the CTRL group ( = 0.018) and more closely resembled that of the BF group. Immune and gut health markers were similar between the SYN and BF groups. No significant differences in AEs were observed across groups.
CONCLUSION
The synbiotic-supplemented infant formula supported healthy, age-appropriate growth, good GI tolerance, and increased the abundance of beneficial through 4 months of age.
CLINICAL TRIAL REGISTRATION
背景与目的
肠道健康与微生物群发育在生命早期紧密相连，人乳寡糖（HMOs）起着关键作用。本研究报告了一项评估含HMOs和益生菌合生元混合物的婴儿配方奶粉试验至4月龄的结果，重点关注从出生到15月龄的生长、胃肠道（GI）耐受性和肠道健康生物标志物。
材料与方法
将≤14日龄的健康婴儿随机分为两组，分别接受实验配方奶粉（SYN；在对照配方奶粉中添加六种HMOs和两种益生菌[, ]）或对照配方奶粉（CTRL；部分水解的100%乳清基配方奶粉）。一个非随机母乳喂养（BF）组作为对照。主要终点是SYN组与CTRL组至4月龄的体重增加速度。次要终点包括粪便指标（双歧杆菌丰度、免疫和肠道健康标志物）、胃肠道耐受性和不良事件（AE）。
结果
全分析集（FAS）包括313名婴儿（SYN组118名，CTRL组114名，BF组81名），而符合方案人群（PP）包括227名婴儿（SYN组84名，CTRL组84名，BF组59名）。在FAS和PP分析中，SYN组至4月龄的体重增加速度均不劣于CTRL组（均 < 0.0001）。在4个月内，SYN组和CTRL组家长报告的胃肠道耐受性和粪便模式相似。在3个月时，SYN组的 丰度显著高于CTRL组（ = 0.004）。SYN组的粪便pH低于CTRL组（ = 0.018），且更接近BF组。SYN组和BF组的免疫和肠道健康标志物相似。各组间不良事件无显著差异。
结论
添加合生元的婴儿配方奶粉支持健康的、符合年龄的生长，良好的胃肠道耐受性，并在4月龄内增加了有益菌的丰度。
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