Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children

Efficacy of Diosmectite (SMECTA®) in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children. A Phase IIIB, Placebo Controlled, Randomized, Double Blind, Parallel Groups, Multicenter Study.

The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.

Inclusion Criteria:

• male
• acute watery diarrhoea defined as at least 3 watery stools per 24 hours
• duration of watery diarrhoea of less than 72 hours and with at least 1 watery stool for the last 12 hours
• dehydration signs requiring oral rehydration according to current WHO guidelines

Exclusion Criteria:

• severe dehydration that needs IV therapy
• presence of gross blood in stools
• fever >39 degrees Celsius