Johnston William H, Ashley Claude, Yeiser Michael, Harris Cheryl L, Stolz Suzanne I, Wampler Jennifer L, Wittke Anja, Cooper Timothy R
Birmingham Pediatric Associates, 806 St Vincent's Drive, Birmingham, AL, 35205, USA.
Southeastern Pediatric Associates, 364 Honeysuckle Road, Dothan, AL, 36305, USA.
BMC Pediatr. 2015 Nov 7;15:173. doi: 10.1186/s12887-015-0488-3.
Human milk provides necessary macronutrients (protein, carbohydrate, fat) required for infant nutrition. Lactoferrin (Lf), a multifunctional iron-binding protein predominant in human milk, shares similar protein sequence, structure, and bioactivity with bovine Lf (bLf). This large-scale pediatric nutrition study was designed to evaluate growth and tolerance in healthy infants who received study formulas with bLf at concentrations within the range of mature human milk.
In this multi-center, double-blind, parallel-designed, gender-stratified prospective study 480 infants were randomized to receive a marketed routine cow's milk-based infant formula (Control; n = 155) or one of two investigational formulas with bLf at 0.6 g/L (LF-0.6; n = 165) or 1.0 g/L (LF-1.0; n = 160) from 14-365 days of age. Investigational formulas also had a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) and adjusted arachidonic acid (ARA). The primary outcome was weight growth rate from 14-120 days of age. Anthropometric measurements were taken at 14, 30, 60, 90, 120, 180, 275, and 365 days of age. Parental recall of formula intake, tolerance, and stool characteristics was collected at each time point. Medically-confirmed adverse events were collected throughout the study period.
There were no group differences in growth rate (g/day) from 14-120 days of age; 353 infants completed the study through 365 days of age (
110; LF-0.6: 127; LF-1.0: 116). Few differences in growth, formula intake, and infant fussiness or gassiness were observed through 365 day of age. Group discontinuation rates and the overall group incidence of medically-confirmed adverse events were not significantly different. From 30 through 180 days of age, group differences in stool consistency (P < 0.005) were detected with softer stools for infants in the LF-0.6 and LF-1.0 groups versus CONTROL.
Compared to the Control, infants who received investigational formulas with bLf and the prebiotic blend of PDX and GOS experienced a softer stooling pattern similar to that reported in breastfed infants. This study demonstrated routine infant formulas with bLf, a blend of PDX and GOS, and adjusted ARA were safe, well-tolerated, and associated with normal growth when fed to healthy term infants through 365 days of age.
ClinicalTrials.gov NCT01122654 . Registered 10 May 2010.
母乳提供婴儿营养所需的必需常量营养素（蛋白质、碳水化合物、脂肪）。乳铁蛋白（Lf）是母乳中一种主要的多功能铁结合蛋白，与牛乳铁蛋白（bLf）具有相似的蛋白质序列、结构和生物活性。这项大规模儿科营养研究旨在评估健康婴儿食用含bLf且浓度在成熟母乳范围内的研究配方奶粉后的生长和耐受性。
在这项多中心、双盲、平行设计、按性别分层的前瞻性研究中，480名婴儿被随机分为接受市售常规牛奶基婴儿配方奶粉（对照组；n = 155）或两种含bLf的研究配方奶粉之一，其中bLf含量分别为0.6 g/L（LF - 0.6组；n = 165）或1.0 g/L（LF - 1.0组；n = 160），从14日龄至365日龄。研究配方奶粉还含有聚葡萄糖（PDX）和低聚半乳糖（GOS）的益生元混合物以及调整后的花生四烯酸（ARA）。主要结局是14至120日龄的体重增长率。在14、30、60、90、120、180、275和365日龄时进行人体测量。在每个时间点收集家长对配方奶粉摄入量、耐受性和粪便特征的回忆。在整个研究期间收集经医学确认的不良事件。
14至120日龄时，各组间生长速率（克/天）无差异；353名婴儿完成了365日龄的研究（对照组：110名；LF - 0.6组：127名；LF - 1.0组：116名）。在365日龄前，在生长、配方奶粉摄入量以及婴儿烦躁或肠胃胀气方面几乎没有差异。各组的停药率和经医学确认的不良事件的总体发生率无显著差异。在30至180日龄期间，检测到LF - 0.6组和LF - 1.0组婴儿的粪便质地比对照组婴儿更软（P < 0.005）。
与对照组相比，接受含bLf以及PDX和GOS益生元混合物的研究配方奶粉的婴儿，其排便模式更软，与母乳喂养婴儿的情况相似。本研究表明，含bLf、PDX和GOS混合物以及调整后的ARA的常规婴儿配方奶粉在喂养健康足月儿至365日龄时是安全的、耐受性良好的，并且与正常生长相关。
ClinicalTrials.gov NCT01122654。于2010年5月10日注册。
