Loperamide in the treatment of acute gastroenteritis in early childhood. Report of a two centre, double-blind, controlled clinical trial.

Loperamide at a dose of 0 . 2 mg/kg/day was compared with placebo in the treatment of acute infantile gastro-enteritis in hospital-based double-blind clinical trials carried out in parallel in Liverpool, England and Benghazi, Libya. Fifty patients aged one month to four years entered the study in each centre. Rotavirus was the predominant pathogen isolated in both centres. Pathogenic Escherichia coli was cultured from five children in the Liverpool study only. No statistically significant differences were observed in the duration of diarrhoea, length of stay in hospital or weight gain during the first 48 h after admission, between loperamide and placebo groups in either centre. Loperamide, in the dosage used in this study, appears to have no significant effect on the course of acute gastro-enteritis in early childhood. The possibility that these results may reflect specifically on rotavirus infection is discussed. No toxic effects of loperamide were observed.