Infant formula containing bovine milk-derived oligosaccharides supports age-appropriate growth and improves stooling pattern

Abstract

Abstract Background 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. Methods 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). Results 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. Conclusions 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. Impact 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.