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

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.

The Link between Different Types of Prebiotics in Infant Formula and Infection Rates: A Review

“…GOSs, alone or supplemented with high-dose β-palmitic acid, did not reduce the incidence of infection [39,41]. The same conclusion was noted for the supplementation of inulin [43] or MOS [42] as prebiotics in infant formula. In one study where GOSs and PDX were combined as a supplement, there was a reduction in RTIs during the period of intervention and a prolonged reduction in recurrent RTIs after ending the prebiotic [40].…”

“…GOS/PDX supplementation during the first 48 weeks of life was reported to reduce URTIs during this period, but this effect could not be confirmed after 96 weeks [40]. GOSs [39], GOSs with high amounts β-palmitic acid [41], and MOSs [42] did not have an impact on this type of infection.…”

“…A second trial showed a relative risk reduction of 33.7% after adding HMOs [37]. MOSs had no influence on LRTIs [42]. Other prebiotic studies did not examine LRTIs.…”

“…In addition to GOSs, other prebiotics were explored. After a supplementation of 7.2 g/L bovine-milk-derived oligosaccharide (MOS) until the age of six months, Estorminos et al observed no differences in upper (59/114 vs. 57/112) and lower (24/114 vs. 24/112) RTIs [42].…”

Concentration and composition of odd-chain fatty acids in phospholipids and triacylglycerols in Chinese human milk throughout lactation

“…Human milk is widely recognized as the optimal nutritional source for infants, providing adequate calories and bioactive nutrients crucial for their growth and developmental requirements. 1 About 50% of the energy from human milk is derived from lipids. 2 Lipids in human milk are distributed within well-structured droplets known as milk fat globules (MFGs), wherein triacylglycerols (TAGs) constitute the core, comprising approximately 98% of the total fat content.…”