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

ABSTRACT

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.