This study aims to evaluate the effect of hyperimmune
immunoglobulin Y (
IgY) against human rotavirus (HRV) among pediatric patients receiving standard supportive treatment for rotavirus-associated
diarrhea mostly with an enteric non-
cholera co-pathogen in a hospital setting. Two natural HRV reassortant clinical strains ATCC VR 2273 and ATCC VR 2274 were used as mixed immunizing
antigens in poultry hens to generate anti-HRV
IgY (Rotamix
IgY). The Rotamix
IgY was used in laboratory and clinical studies against control or placebo
IgY. The control or placebo
IgY was prepared using tissue culture medium from mock-infected MA104 cell line as
antigen for poultry immunization. In vitro, Rotamix
IgY exhibited multi-serotypic cross neutralization activities along with synergistic effects against major global serotypes G1, G2, G3, G4 and other human or animal rotavirus strains when compared with mono-specific
IgY. Suckling mice (ICR strain) pre-treated orally once with Rotamix
IgY and then challenged with rotavirus 3h later showed a significant dose-dependent reduction in frequency (p<0.05) and duration (p<0.05) of
diarrhea compared to placebo
IgY-treated mice. Out of 114 children aged between 3 and 14 months and with
diarrhea upon admission in a Myanmar hospital, 54 dehydrated and rotavirus-positive children were randomized into Rotamix
IgY group and placebo
IgY group. Of these, only 52 children had complete data with n=26 children per study group. Ninety-two percent of patients in each of these groups were positive for co-infecting enteric non-
cholera pathogen and all patients received standard supportive
therapy for
diarrhea. The patients were monitored for volume and duration of
oral rehydration fluid (ORF) and intravenous fluid (IVF) intake, daily stool frequency and overall duration of
diarrhea, and frequency and duration of rotavirus shedding. Compared to placebo
IgY group, the Rotamix
IgY group had statistically significant reduction in mean ORF intake (p=0.004), mean duration of intravenous fluid administration (p=0.03), mean duration of
diarrhea from day of admission (p<0.01) and mean duration of rotavirus clearance from stool from day of admission (p=0.05). Overall, our novel approach using oral Rotamix
IgY for rotavirus-infected children mostly with non-
cholera enteric pathogen
co-infection appears to be a promising, safe and effective adjunct to management of acute
diarrhea in pediatric patients.