Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN 47721, USA.
Nutr J. 2012 Jun 7;11:38. doi: 10.1186/1475-2891-11-38.
To ensure the suitability of an infant formula as the sole source of nutrition or provide benefits similar to outcomes in breastfed infants, advancements in formula composition are warranted as more research detailing the nutrient composition of human milk becomes available. This study was designed to evaluate growth and tolerance in healthy infants who received one of two investigational cow's milk-based formulas with adjustments in carbohydrate, fat, and calcium content and supplemented with a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) or GOS alone.
In this multi-center, double-blind, parallel-designed, gender-stratified prospective study 419 infants were randomized and consumed either a marketed routine cow's milk-based infant formula (Control; Enfamil® LIPIL®, Mead Johnson Nutrition, Evansville, IN) (n = 142) or one of two investigational formulas from 14 to 120 days of age. Investigational formulas were supplemented with 4 g/L (1:1 ratio) of a prebiotic blend of PDX and GOS (PDX/GOS; n = 139) or 4 g/L of GOS alone (GOS; n = 138). Anthropometric measurements were taken at 14, 30, 60, 90, and 120 days of age. Daily recall of formula intake, tolerance, and stool characteristics was collected during study weeks 1 and 2 and 24-h recall was collected at 60, 90, and 120 days of age. Medically-confirmed adverse events were recorded throughout the study.
There were no group differences in growth rate from 14 to 120 days of age. Discontinuation rates were not significantly different among study groups. No differences in formula intake or infant fussiness or gassiness were observed. During study weeks 1 and 2 and at 60 days of age stool consistency ratings were higher (i.e. softer stools) for infants in the PDX/GOS and GOS groups versus Control and remained higher at 120 days for the PDX/GOS group (all P < 0.05). The overall incidence of medically-confirmed adverse events was similar among groups.
Investigational routine infant formulas supplemented with 4 g/L of either a prebiotic blend of PDX and GOS or GOS alone were well-tolerated and supported normal growth. Compared to infants who received the unsupplemented control formula, infants who received prebiotic supplementation experienced a softer stooling pattern similar to that reported in breastfed infants.
ClinicalTrials.gov Identifier: NCT00712608.
为确保婴儿配方奶粉能作为唯一的营养来源，或者提供与母乳喂养婴儿相似的效果，需要对配方奶粉的成分进行改进，因为更多的研究详细说明了人乳的营养成分。本研究旨在评估健康婴儿在接受两种以牛奶为基础的配方奶粉之一后的生长和耐受性，这两种配方奶粉在碳水化合物、脂肪和钙含量方面进行了调整，并添加了一种由多聚葡萄糖（PDX）和半乳糖寡糖（GOS）组成的预混物或单独的 GOS。
在这项多中心、双盲、平行设计、性别分层的前瞻性研究中，419 名婴儿被随机分为两组，分别接受市售常规牛奶配方奶粉（对照组；Enfamil® LIPIL®，美赞臣营养品，印第安纳州埃文斯维尔）（n=142）或两种研究配方奶粉之一，从 14 至 120 天龄。研究配方奶粉中添加了 4g/L（1:1 比例）的 PDX 和 GOS 预混物（PDX/GOS；n=139）或 4g/L 的 GOS 单独添加（GOS；n=138）。在 14、30、60、90 和 120 天龄时测量体格测量值。在研究周 1 和 2 以及 60、90 和 120 天龄时收集配方奶摄入量、耐受性和粪便特征的每日回忆，并在 60、90 和 120 天龄时进行 24 小时回忆。在整个研究过程中记录经医学确认的不良事件。
从 14 至 120 天龄，两组的生长速度无差异。研究组的停药率无显著差异。未观察到配方奶摄入量或婴儿烦躁或胀气的差异。在研究周 1 和 2 以及 60 天龄时，PDX/GOS 和 GOS 组的粪便稠度评分（即较软的粪便）高于对照组，PDX/GOS 组在 120 天龄时仍较高（均 P<0.05）。各组经医学确认的不良事件总体发生率相似。
添加 4g/L 的 PDX 和 GOS 预混物或 GOS 的常规婴儿配方奶粉耐受性良好，并支持正常生长。与接受未添加预混物的对照配方奶粉的婴儿相比，接受预混物补充的婴儿的粪便模式较软，类似于母乳喂养婴儿的报告模式。
ClinicalTrials.gov 标识符：NCT00712608。
