背景:这项研究的目的是评估生长,在预期使用的婴儿人群中,添加2'-FL的广泛水解配方奶粉的耐受性和依从性效果。
方法:非随机,单组,进行了多中心研究。怀疑食物蛋白过敏的婴儿(0-60日龄),持续的喂养不耐受,在一项为期2个月的饲喂试验中,或出现了认为合适的广泛水解配方(eHF)的情况。主要结果是在研究期间年龄z评分的体重维持。重量,长度,头围,配方摄入量,公差措施,收集临床症状和问卷调查。纳入48名婴儿,36名完成了研究。
结果:从研究第1天到研究第60天,婴儿体重(年龄)z评分显示出统计学上的显着改善(0.32±0.11,p=0.0078)。
结论:总体而言,研究结果表明,该研究配方具有良好的耐受性,预期人口的安全和支持增长。
BACKGROUND: The purpose of this study was to evaluate the growth, tolerance and compliance effects of an extensively hydrolyzed formula with added 2\'-FL in an intended use population of infants.
METHODS: A non-randomized, single-group, multicenter study was conducted. Infants (0-60 days of age) with suspected food protein allergy, persistent feeding intolerance, or presenting conditions where an extensively hydrolyzed formula (eHF) was deemed appropriate were enrolled in a 2-month feeding trial. The primary outcome was maintenance of weight for age z-score during the study. Weight, length, head circumference, formula intake, tolerance measures, clinical symptoms and questionnaires were collected. Forty-eight infants were enrolled and 36 completed the study.
RESULTS: Weight for age z-scores of infants showed a statistically significant improvement from study day 1 to study day 60 (0.32 ± 0.11, p = 0.0078).
CONCLUSIONS: Overall, the results of the study demonstrate that the study formula was well tolerated, safe and supported growth in the intended population.