Growth and tolerance of formula with lactoferrin in infants through one year of age: double-blind, randomized, controlled trial

Abstract

BackgroundHuman milk provides necessary macronutrients (protein, carbohydrate, fat) required for infant nutrition. Lactoferrin (Lf), a multifunctional iron-binding protein predominant in human milk, shares similar protein sequence, structure, and bioactivity with bovine Lf (bLf). This large-scale pediatric nutrition study was designed to evaluate growth and tolerance in healthy infants who received study formulas with bLf at concentrations within the range of mature human milk.MethodsIn this multi-center, double-blind, parallel-designed, gender-stratified prospective study 480 infants were randomized to receive a marketed routine cow’s milk-based infant formula (Control; n = 155) or one of two investigational formulas with bLf at 0.6 g/L (LF-0.6; n = 165) or 1.0 g/L (LF-1.0; n = 160) from 14–365 days of age. Investigational formulas also had a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) and adjusted arachidonic acid (ARA). The primary outcome was weight growth rate from 14–120 days of age. Anthropometric measurements were taken at 14, 30, 60, 90, 120, 180, 275, and 365 days of age. Parental recall of formula intake, tolerance, and stool characteristics was collected at each time point. Medically-confirmed adverse events were collected throughout the study period.ResultsThere were no group differences in growth rate (g/day) from 14–120 days of age; 353 infants completed the study through 365 days of age (Control: 110; LF-0.6: 127; LF-1.0: 116). Few differences in growth, formula intake, and infant fussiness or gassiness were observed through 365 day of age. Group discontinuation rates and the overall group incidence of medically-confirmed adverse events were not significantly different. From 30 through 180 days of age, group differences in stool consistency (P < 0.005) were detected with softer stools for infants in the LF-0.6 and LF-1.0 groups versus Control.ConclusionCompared to the Control, infants who received investigational formulas with bLf and the prebiotic blend of PDX and GOS experienced a softer stooling pattern similar to that reported in breastfed infants. This study demonstrated routine infant formulas with bLf, a blend of PDX and GOS, and adjusted ARA were safe, well-tolerated, and associated with normal growth when fed to healthy term infants through 365 days of age.Trial registrationClinicalTrials.gov NCT01122654. Registered 10 May 2010.

The effects of prebiotic supplementation on weight gain, diarrhoea, constipation, fever and respiratory tract infections in the first year of life

“…19 In another study, GOS (galactooligosaccharides)-PDX prebiotic formula supplemented with arachidonic acid and lactoferrin also demonstrated no significant effect on weight gain in babies within the first year of life. 20 Similar results were also reported by others regarding the GOS:FOS regimen. 21,22 Clinically, weight status and its appropriate pattern during development is among the most critical parameters of babies' health.…”

“…there was also no significant difference between standard formula and PF regarding bodyweight . In another study, GOS (galactooligosaccharides)‐PDX prebiotic formula supplemented with arachidonic acid and lactoferrin also demonstrated no significant effect on weight gain in babies within the first year of life . Similar results were also reported by others regarding the GOS:FOS regimen .…”

Human Milk Casein and Whey Protein and Infant Body Composition over the First 12 Months of Lactation

“…Administered bovine and HM lysozyme [ 58 , 59 ] have been linked to increased weight gain in preterm infants. Furthermore, high levels of lactoferrin in bovine formula was associated with lower weight gain rate in healthy term female infants during first two months after birth compared with control [ 60 ]. Interestingly, α-lactalbumin-enriched formula did not result in any differences in weight gain, weight-for-age and weight-for-length z-scores compared with breastfed infants or infants fed standard formula at four months of age [ 61 ].…”

Developmental effects on sleep–wake patterns in infants receiving a cow’s milk-based infant formula with an added prebiotic blend: a Randomized Controlled Trial

“…12 In healthy term infants, we have previously demonstrated a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) (4 g/L, 1:1 ratio) in infant formula was well tolerated, supported normal growth, promoted softer stools closer to that of breastfed infants, and had a bifidogenic effect closer to breast milk when compared to infants fed a formula without the added prebiotic blend. [13][14][15][16][17] This same blend of PDX and GOS has also been associated with development of typical behavioral states in preterm infants who demonstrated a significant reduction in excessive crying. 18 These data are consistent with the hypothesis that prebiotics may have an impact on broader brain-mediated behaviors.…”