Methods | Quasi‐randomized controlled trial Length of follow‐up: 5 days |
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Participants | Number: 71 infants and children Inclusion criteria: inpatients; infants and children (no age limit specified, mean age of 13 months) with acute watery diarrhoea < 7 days duration, with mild‐to‐moderate dehydration Exclusion criteria: systemic illness; previous use of antibiotics or antidiarrhoeal agents; malnutrition Breastfeeding: included |
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Interventions | Intervention group: diosmectite. Dosage 1.5 g every 8 hours to infants < 10 kg, 1.6 g every 6 hours to infants > 10 kg for a maximum of 5 days Control: no medication |
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Outcomes | Clinical resolution (return of stools to previous formed consistency and average number of frequency) Stool output (g/kg) Stool frequency |
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Notes | Location: Egypt Setting: urban Cause of diarrhoea: rotavirus 43%, bacterial (not specified) 23% Source of funding: not specified |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Not truly random; participants selected alternately. |
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 | High risk | Per‐protocol analysis with 4 exlusions in intervention group (12%) and 7 losses in control group (19%) |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement. No protocol registered. |
Other bias | Unclear risk | No other biases detected. |