A double-blind, placebo-controlled, pilot study of bovine lactoferrin supplementation in bottle-fed infants

J Pediatr Gastroenterol Nutr. 2007 Feb;44(2):245-51. doi: 10.1097/01.mpg.0000243435.54958.68.


Background: Lactoferrin has an array of biological activities that include growth, immune modulation, and antimicrobial effects. The aim of this randomized, placebo-controlled, double-blind study was to examine the impact of bovine lactoferrin supplementation in infants.

Patients and methods: Healthy, formula-fed infants, > or =34 weeks' gestation and < or =4 weeks of age, enrolled in a pediatric clinic. Infants received either formula supplemented with lactoferrin (850 mg/L) or commercial cow milk-based formula (102 mg/L) for 12 months. Growth parameters and information on gastrointestinal, respiratory, and colic illnesses were collected for the infants' first year. Antibodies to immunizations and hematologic parameters were measured at 9 and 12 months.

Results: The lactoferrin-enhanced formula was well tolerated. There were significantly fewer lower respiratory tract illnesses, primarily wheezing, in the 26 lactoferrin-fed (0.15 episodes/y) compared with the 26 regular formula-fed (0.5 episodes/y) infants (P < 0.05). Significantly higher hematocrit levels at 9 months (37.1% vs 35.4%; P < 0.05) occurred in the lactoferrin-supplemented group compared with the control formula group.

Conclusions: Lactoferrin supplementation was associated with potentially beneficial outcomes such as significantly fewer lower respiratory tract illnesses and higher hematocrits. Larger, more focused studies in infants are warranted.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Bottle Feeding*
  • Cattle
  • Child Development / physiology*
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Infant Formula*
  • Infant, Newborn
  • Lactoferrin / therapeutic use*
  • Male
  • Pilot Projects


  • Lactoferrin