Treatment of enterotoxigenic and enteropathogenic Escherichia coli-induceddiarrhoea in children with bovine immunoglobulin milk concentrate from hyperimmunized cows: A double-blind, placebo-controlled, clinical trial

Background: Enterotoxigenic Escherichia coli (ETEC) and enteropathogenic Es cherichia coli (EPEC) are important causes of diarrhoea in young children a nd are associated with significant mortality rates. Passive immunization wi th antibodies from immunized cows has previously been shown to be effective as prophylaxis against E. coil-induced diarrhoea and therapeutically again st rotavirus and cryptosporidia-induced diarrhoea. Methods: We tested the t herapeutic efficacy of an oral bovine immunoglobulin milk concentrate (BIC) from cows hyperimmunized with ETEC and EPEC strains, in a randomized, plac ebo-controlled study in children with E. coil-induced diarrhoea. Eighty-six children between 4-24 months of age attending the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B) with E. coli-induced di arrhoea (63 EPEC/ETEC and 23 with other diarrhoeagenic E. coli) were random ly assigned to receive orally administered BIC (20 g) containing anti ETEC/ EPEC antibodies or a placebo preparation daily for 4 consecutive days. Dail y stool output, intake of oral rehydration solution (ORS), stool frequency, and presence of diarrhoeagenic E. coli strains in the stool were monitored for 4 days. Results: Children in the treatment group tolerated the BIC wit h no side effects. There were no significant differences between the two gr oups with regard to ORS intake, stool output, frequency of diarrhoea, or cl earance of pathogen. Nor was there any significant alteration in the durati on of diarrhoea. Conclusions: In contrast to the prophylactic efficacy of a nti-E. coli BIC and the therapeutic efficacy of a similarly prepared anti-r otavirus BIG, antibodies from hyperimmunized cows appear to have no signifi cant therapeutic benefit in the treatment of acute diarrhoea due to EPEC/ET EC.