The aim of this case-control study, was to estimate clinical effects, safety and parents' assessment of Diosmectite, in acute infantile diarrhoea. Thirty-five children aged 0-5 years, with acute diarrhoea from at least 5 days received alternatively oral rehydration solution (ORS) and Diosmectite (3 g/day for 3 days in children aged under 3 years and 6 g/day for 3 days in children aged over 3 years) (16 cases) or ORS only (19 cases). At discharge, parents' opinion concerning satisfaction for treatment received was evaluated through a questionnaire. Differences in the amount of liquid intake, weigh recovery, resolution of fever, resolution of vomiting and number of loose stools in the first 48 hours of hospitalization were not significant. Diosmectite was well tolerated and no major side effects were found. Parents' satisfaction for therapy resulted higher in the treated group than in the control group, even if differences were not significant. Treatment with ORS and Diosmectite allowed to shorten the mean duration of hospitalization by 0.4 days/children in the treatment group compared to the control group. Further studies with more cases and with higher does of the drug are necessary to confirm our results.