title: Growth and tolerance of formula with lactoferrin in infants through one year of age: double-blind, randomized, controlled trial.
abstract: BACKGROUND
  Human 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.
  
  
  METHODS
  In 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.
  
  
  RESULTS
  There 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 (
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Compared 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01122654 . Registered 10 May 2010.
authors.affiliation: Birmingham Pediatric Associates, 806 St Vincent's Drive, Birmingham, AL, 35205, USA. william.johnston@medsearchrx.com.
authors.forename: William H
authors.initials: WH
authors.lastname: Johnston
authors.affiliation: Southeastern Pediatric Associates, 364 Honeysuckle Road, Dothan, AL, 36305, USA. drashley@sepeds.com.
authors.forename: Claude
authors.initials: C
authors.lastname: Ashley
authors.affiliation: Owensboro Pediatrics, 2200 E. Parrish Avenue, Owensboro, KY, 42303, USA. Myeiser@owensboropediatrics.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Yeiser
authors.affiliation: Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN, 47721, USA. cheryl.harris@mjn.com.
authors.forename: Cheryl L
authors.initials: CL
authors.lastname: Harris
authors.affiliation: Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN, 47721, USA. suzanne.stolz@mjn.com.
authors.forename: Suzanne I
authors.initials: SI
authors.lastname: Stolz
authors.affiliation: Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN, 47721, USA. jennifer.wampler@mjn.com.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Wampler
authors.affiliation: Global Research and Development, Mead Johnson Nutrition, Evansville, IN, 47721, USA. anja.wittke@mjn.com.
authors.forename: Anja
authors.initials: A
authors.lastname: Wittke
authors.affiliation: Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN, 47721, USA. timothy.cooper@mjn.com.
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Cooper
mesh_terms: D000818:Animals; D002417:Cattle; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000008:administration & dosage / Q000737:chemistry*; D007231:Infant, Newborn; D007781:Lactoferrin / Q000032:analysis*; D008297:Male; D008892:Milk / Q000737:chemistry*; D056692:Prebiotics / Q000032:analysis*; D011446:Prospective Studies; D015430:Weight Gain / Q000502:physiology*
chemical_list: D056692:Prebiotics; D007781:Lactoferrin