Methods | Randomized controlled trial Length of follow‐up: not stated |
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Participants | Number: 36 enrolled infants Inclusion criteria: inpatients; infants aged 2 to 24 months with acute watery diarrhoea < 4 days duration, with mild‐to‐moderate dehydration Exclusion criteria: previous medications, concomitant illness Breastfeeding: not stated |
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Interventions | Intervention group: diosmectite. Dosage 3 g per day to infants < 1 year, 6 g per day to infants > 1 year. Duration not stated. Control: placebo |
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Outcomes | Duration of diarrhoea (from first drug administration to last liquid stool before a formed one) Clinical resolution at day 3 and 5 Adverse events |
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Notes | Location: France Setting: urban Cause of diarrhoea: rotavirus 77% Source of funding: not specified |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Stated as "drawing lots" |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
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 | Use of placebo; probably adequate blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 loss per group |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement. No protocol registered. |
Other bias | Low risk | No other biases detected. |