Use of bismuth subsalicylate in acute diarrhea in children.

Results of a pilot study suggest that bismuth subsalicylate (BSS) favorably altered the course of rotavirus-associated diarrhea in children. This was more evident in those who also had a bacterial pathogen. Subsequently, 123 infants and children with acute diarrhea were admitted to a randomized, parallel, double-blind, placebo-controlled clinical trial. Patients received either BSS at a dosage of 100 mg/(kg.d) for 5 days or a placebo. Patients in the two groups were comparable with respect to age, sex, weight, height, and baseline disease parameters. Compared with subjects treated with placebo, those who received BSS had significantly lower stool weight sooner; improved stool consistency sooner; shorter hospital stay; lower number of stools; decreased need for intravenous fluids; and better evolution of clinical condition. The maximum mean serum level of salicylate occurred on day 3, and the mean blood level of bismuth on the last day of dosing (day 5) was 5.8 ppb.