Effects of lactoferrin-containing formula in the prevention of enterovirus and rotavirus infection and impact on serum cytokine levels: a randomized trial.

Background: Lactoferrin has been shown to exhibit anti-enterovirus 71 (EV71) and antirotavirus properties. This trial was conducted to determine whether a formula containing bovine lactoferrin (bLF) exerts a protective effect against EV71 or rotavirus infection among children from 2 to 6 years old.

Methods: A prospective, randomized, single blind clinical trial of an oral supplement containing bLF (daily dose approximately 70 to 85 mg) was carried out with healthy children in a day care center from March 2002 to June 2003. The incidence of enterovirus or rotavirus infection and the serum level of interferon- gamma (IFN-γ) and interleukin-10 (IL-10) were compared between children receiving and not receiving bLF.

Results: A total of 172 children, 96 in group A, which received bLF, and 76 in group B which did not receive bLF, completed the trial. During the study period, no EV71 was isolated and seroconversion of EV71 antibodies was noted in only one child. Fourteen episodes of presumptive enterovirus infection and 12 episodes of presumptive viral enteritis were detected. No significant differences were observed between groups in the incidence of presumptive enterovirus infection or viral enteritis or the number of laboratory confirmed enterovirus or rotavirus infections. No significant differences were observed in the serum levels of IFN-γ and IL-10 between groups either prior to or following the trial. In both groups, IFN-γ levels increased, but IL-10 was unchanged following the trial.

Conclusion: An oral supplement of bLF at a dose of 70 mg/day did not show any benefits in the prevention of EV71 or rotavirus infection, or any impact on IFN-γ or IL-10 serum levels in healthy children in this trial.