Loperamide in acute diarrhoea in childhood: results of a double blind, placebo controlled multicentre clinical trial. Diarrhoeal Diseases Study Group (UK).

A total of 315 young children with acute diarrhoea were included in a double blind, hospital based multicentre trial of loperamide at two dose levels (0.8 mg and 0.4 mg/kg/24 h), given with standard oral rehydration therapy versus placebo plus oral rehydration therapy. The overall recovery rate was slowest in the placebo group and fastest in the group given loperamide 0.8 mg. Comparisons between weights on admission and weights by day 3 showed that a larger proportion of children in the loperamide groups gained weight than in the placebo group. No serious side effects of loperamide were observed, but the drug was withdrawn in one infant because of mild abdominal distention. The results indicate that loperamide, in the doses employed, is safe and may in selected cases be a useful adjunct to oral rehydration in the management of acute diarrhoea in well nourished children.