Methods | Randomized controlled trial Length of follow‐up: not stated |
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Participants | Number: 56 enrolled children Inclusion criteria: inpatients; children aged 2 to 24 months with moderate‐to‐severe acute diarrhoea Exclusion criteria: malnutrition 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: placebo Another control group received loperamide 0.11 mg/kg every 8 hours. |
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Outcomes | Duration of diarrhoea (time to normalization of stools) Stool frequency on day 5 |
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Notes | Location: France Setting: urban Cause of diarrhoea: rotavirus 18%, Staphylococcus aureus 3%, Escherichia coli 3%, Campylobacter spp. 3%, Candida spp. 1% Source of funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stated as randomized but no method described. |
Allocation concealment (selection bias) | Unclear risk | No method described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Use of placebo; probably adequate blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Per‐protocol analysis. 4 children (7%) excluded and not analysed. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement. No protocol registered. |
Other bias | Low risk | No other biases detected. |