Our data indicate that infants fed formula supplemented with 2'-FL exhibit lower plasma and ex vivo inflammatory cytokine profiles, similar to those of a breastfed reference group. This trial was registered at clinicaltrials.gov as NCT01808105.

Objectives:The aim of the present study was to examine the growth and tolerance of infants fed infant formulas with a caloric density closer to human milk (HM) supplemented with human milk oligosaccharides (HMOs) and to study uptake of the HMOs.Methods:A prospective, randomized, controlled, growth and tolerance study was conducted in healthy, singleton infants (birth weight ≥2490 g), who were enrolled by day of life (DOL) 5. Formula-fed infants were randomized to 1 of 3 formulas with a caloric density of 64.3 kcal/dL. Each formula contained galactooligosaccharides, and the 2 experimental formulas contained varying levels (0.2 and 1.0 g/L) of the HMO 2′-fucosyllactose (2′FL). The 3 formula groups were compared with an HM-fed reference group. Infants were exclusively fed either formula (n = 189) or HM (n = 65) from enrollment to 119 DOL. 2′FL was measured in the blood and urine collected from a subset of infants at DOL 42 and 119, and in HM collected from breast-feeding mothers at DOL 42.Results:There were no significant differences among any groups for weight, length, or head circumference growth during the 4-month study period. All of the formulas were well tolerated and comparable for average stool consistency, number of stools per day, and percent of feedings associated with spitting up or vomit. 2′FL was present in the plasma and urine of infants fed 2′FL, and there were no significant differences in 2′FL uptake relative to the concentration fed.Conclusions:This is the first report of infants fed 2′FL-fortified formulas with a caloric density similar to HM. Growth and 2′FL uptake were similar to those of HM-fed infants.