Methods | Quasi‐randomized controlled trial Length of follow‐up: not stated |
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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 |
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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 |
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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 |
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Notes | Location: Italy Setting: urban Cause of diarrhoea: rotavirus 4%, not specified bacterial aetiology 1% Source of funding: industry |
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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. |