Skip to main content
. 2018 Apr 25;2018(4):CD011526. doi: 10.1002/14651858.CD011526.pub2
Methods Quasi‐randomized controlled trial
Length of follow‐up: not stated
Participants Number: 804 enrolled children
Inclusion criteria: outpatients; well‐nourished children aged 3 to 60 months with acute diarrhoea of mild‐to‐moderate severity < 2 days duration, with 3 watery stools per day
Exclusion criteria: malnutrition, chronic diseases, previous medications
Breastfeeding: not specified
Interventions Intervention group: diosmectite. Dosage 1.5 g twice a day for infants younger than 12 months. Double the dose for older children
Control: no medication
Outcomes Duration of diarrhoea (from first to the last liquid–loose stool output preceding the return of normal stools)
Diarrhoea at day 7
Vomiting
Fever
Hospitalization rate
Notes Location: Italy
Setting: urban
Cause of diarrhoea: rotavirus 4%, not specified bacterial aetiology 1%
Source of funding: industry
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Not randomized. Participants selected in sequential one‐to‐one basis.
Allocation concealment (selection bias) High risk Not concealed
Blinding of participants and personnel (performance bias) All outcomes High risk Not blinded
Blinding of outcome assessment (detection bias) All outcomes High risk Not blinded
Incomplete outcome data (attrition bias) All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement. No protocol registered.
Other bias Low risk No other biases detected.