A community based clinical study was carried out in childcare centres to evaluate the health and economic outcomes associated with the daily use of an equivalent liquid product containing hyperimmune bovine colostrum - antirotavirus (HBC-A).  The study was a double blinded, two-way parallel, cluster randomised design in over 700 children aged less than four(4) years who were attending 22 childcare centres in South Australia,  over a period of five months.  Children received active product (HBC-A), control (milk), or no product but were monitored.  There are no statistical data available to accurately report on the compliance rate with study treatment.  The number proven rotavirus infections in each group was divided by the person-time at risk of developing an infection for the respective group to yield incidence rates.  The incidence of rotavirus diarrhoea in children given HBC-A was 0.04672/100 days of observation (n=245, observed over 21,403 days with one episode of diarrhoea).  The incidence of rotavirus diarrhoea in children given cows' milk or monitoring only was 0.25431/1000 days (n=497, observed over 47,186 days, 12 episodes of rotavirus diarrhoea).  The analyses are summarised as:

1.    Adjusted for sex, race and stool consistence at baseline, the incidence density (IDR) ratio is 0.22, 95% confidence interval; 0.66 to 0.77, P = 0.018, showing a statistically significant protective effect of HBC-A.

2.    The IDR of rotavirus diarrhoea for treated versus monitored in the active centres was 0.19, significantly different from 1; P = 0.03, the IDR for treated versus monitored in the Control centres was 0.83, not significant: P = 0.69, the ratio of these two IDR's (0.19/0.083) is 0.229 and that this is significantly different from 1: P = 0.0436, that is, there is an interaction.

3.    Children in active centres on the product are less likely to get rotavirus diarrhoea than those being monitored (P = 0.003), and this is a significantly different result than for children receiving control (whole milk) in control centres (P = 0.436).