Randomized, placebo-controlled, clinical trial of hyperimmunized chicken egg yolk immunoglobulin in children with rotavirus diarrhea

Background: Hyperimmunized bovine colostrum containing antibodies has been shown to be effective in the treatment of rotavirus diarrhea. Antibodies de rived from eggs of immunized hens may be a less expensive and more practica l alternative. In this study, children with proven rotavirus diarrhea were treated with immunoglobulin extracted from eggs of chicken immunized with h uman rotavirus strains. Methods: In a randomized, double-blind study, 79 children with known rotavi rus diarrhea were assigned to receive either 10 g hyperimmune egg yolk (HEY ) daily in four equally divided doses for 4 days (HEY group) or a similar p reparation obtained from nonimmunized chicken (placebo group). The daily st ool frequency and amount, oral rehydration solution (ORS) intake, and prese nce of rotavirus in the stool were monitored for 4 days. Results: In the HEY-treated group. there was significant reduction in stool output (in grams per kilogram per day; HEY vs. placebo; 87 +/- 59 vs. 120 +/- 75, P = 0.03), and significant reduction of ORS intake tin milliliters per kilogram per day) (HEY vs. placebo; 84 +/- 46 vs. 122 +/- 72, P = 0.008 ) on day 1 and clearance of virus on day 4 (HEY vs. placebo; 73% vs. 36%, P = 0.02). There was, however, no difference in diarrheal duration between t he groups. Conclusions: Treatment with HEY against four human rotavirus strains result ed in modest improvement of diarrhea associated with earlier clearance of r otavirus from stools. These results indicate an encouraging role of HEY in the treatment of rotavirus-induced diarrhea in children. Further studies ar e needed to optimize the dose and neutralization titer and thus improve the efficacy of egg yolk immunoglobulin IgY derived from immunized hens.