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

Autor: Estorninos E; Asian Hospital and Medical Center, Muntinlupa City, Philippines., Lawenko RB; Asian Hospital and Medical Center, Muntinlupa City, Philippines., Palestroque E; Asian Hospital and Medical Center, Muntinlupa City, Philippines., Lebumfacil J; Wyeth Nutrition, Makati City, Manila, Philippines., Marko M; Nestlé Product Technology Center - Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland., Cercamondi CI; Nestlé Product Technology Center - Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland. ColinIvano.Cercamondi@nestle.com.
Jazyk: angličtina
Zdroj: Pediatric research [Pediatr Res] 2022 May; Vol. 91 (6), pp. 1485-1492. Date of Electronic Publication: 2021 May 06.
DOI: 10.1038/s41390-021-01541-3
Abstrakt: 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.
(© 2021. The Author(s).)
Databáze: MEDLINE
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