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

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.