Asian Hospital and Medical Center, Muntinlupa City, Philippines.
Wyeth Nutrition, Makati City, Manila, Philippines.
Pediatr Res. 2022 May;91(6):1485-1492. doi: 10.1038/s41390-021-01541-3. Epub 2021 May 6.
Adding bovine milk-derived oligosaccharides (MOS) enhances the oligosaccharide profile of infant formula. This study aimed to evaluate the safety and efficacy of a MOS-supplemented infant formula.
In this double-blind randomized controlled trial, healthy infants 21-26 days old were either assigned to bovine milk-based, alpha-lactalbumin, and sn-2 palmitate enriched infant formula (control, n = 115) or the same formula with 7.2 g MOS/L (test, n = 115) until aged 6 months. Co-primary endpoints were weight gain through 4 months and stool consistency (validated scale: 1 = watery to 5 = hard). Secondary endpoints included parent-reported GI tolerance, health-related quality of life (HRQoL), and adverse events (AEs).
Weight gain was similar (p = 0.695); the difference between test and control (mean; 95% CI: 0.29; -1.15, 1.73 g/day) was above the non-inferiority margin (-3 g/day). Test had softer stools than control (mean difference in stool consistency score: -0.31; 95% CI: -0.42, -0.21; P < 0.0001); fewer parental reports of harder stools (OR = 0.32, 95% CI: 0.20, 0.49; P < 0.0001) and less difficulties in passing stool (OR = 0.25, 95% CI: 0.09, 0.65; P = 0.005). Parent-reported GI tolerance and HRQoL were similar between groups as were the overall low AEs.
MOS-supplemented infant formula is safe and well-tolerated while supporting normal infant growth and promotes softer stooling pattern without increasing parent-reported and physician-confirmed adverse health concerns.
This is the first study investigating the addition of bovine milk-derived oligosaccharides to an infant formula enriched with alpha-lactalbumin and elevated levels of sn-2 palmitate, providing safety and efficacy data for such a formula. Term infant formula supplemented with 7.2 g bovine milk-derived oligosaccharides per liter supported normal infant growth, was well-tolerated and safe. Addition of bovine milk-derived oligosaccharides to term infant formula promoted softer stooling pattern and reduced difficulties in passing stool. The study shows that bovine milk-derived oligosaccharide supplemented infant formula is a safe and effective option for healthy term infants who are formula-fed.
添加牛乳来源的低聚糖（MOS）可增强婴儿配方奶粉的低聚糖组成。本研究旨在评估添加 MOS 的婴儿配方奶粉的安全性和有效性。
在这项双盲随机对照试验中，21-26 天大的健康婴儿被随机分配至基于牛乳的、富含α-乳白蛋白和 sn-2 棕榈酸酯的婴儿配方奶粉（对照组，n=115）或相同配方但添加 7.2 g MOS/L 的婴儿配方奶粉（试验组，n=115），直至 6 月龄。主要复合终点为 4 月龄时的体重增长和粪便稠度（经验证的量表：1=水样至 5=硬）。次要终点包括父母报告的胃肠道耐受性、健康相关生活质量（HRQoL）和不良事件（AE）。
体重增长相似（p=0.695）；试验组与对照组之间的差异（均值；95%CI：0.29；-1.15，1.73 g/天）高于非劣效性边界（-3 g/天）。试验组的粪便比对照组更软（粪便稠度评分的平均差异：-0.31；95%CI：-0.42，-0.21；P<0.0001）；父母报告的硬便更少（OR=0.32，95%CI：0.20，0.49；P<0.0001）和排便困难更少（OR=0.25，95%CI：0.09，0.65；P=0.005）。两组间父母报告的胃肠道耐受性和 HRQoL 相似，总体不良事件发生率较低。
添加 MOS 的婴儿配方奶粉安全且耐受良好，同时支持正常婴儿生长，并促进更软的粪便模式，而不会增加父母报告和医生确认的健康问题。
这是第一项研究，调查了在富含α-乳白蛋白和 sn-2 棕榈酸酯的婴儿配方奶粉中添加牛乳来源的低聚糖，为这种配方提供了安全性和有效性数据。每升添加 7.2 g 牛乳来源的低聚糖的配方奶粉支持正常婴儿生长，耐受良好且安全。在配方奶中添加牛乳来源的低聚糖可促进更软的粪便模式并减少排便困难。该研究表明，添加牛乳来源的低聚糖的配方奶是健康足月婴儿配方喂养的安全有效选择。
