Methods | Randomized controlled trial Length of follow‐up: not stated |
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Participants | Number: 300 enrolled children Inclusion criteria: inpatients; well‐nourished male infants and children aged 1 to 36 months with watery diarrhoea < 3 days duration, with 3 watery stools per day and at least 1 watery stool in the past 24 hours; mild‐to‐moderate dehydration Exclusion criteria: severe dehydration or malnutrition, bloody diarrhoea, fever 39 ºC or higher, previous medications Breastfeeding: exclusively breastfed infants were excluded |
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Interventions | Intervention group: diosmectite. Dosage 3 g twice a day for 3 days, then 3 g daily for infants younger than 12 months. Double the dose for older children Control: placebo |
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Outcomes | Duration of diarrhoea (until first formed stool) Stool output in g/kg in the first 72 hrs |
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Notes | Location: Peru Setting: urban Cause of diarrhoea: rotavirus 22%. Other aetiologies not specified. Source of funding: industry Registration number: NCT00352716 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Described as randomized in sequential ascending order by a statistician |
Allocation concealment (selection bias) | Low risk | Sponsor‐assigned biostatistician prepared a list of treatment allocation codes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo was identical to diosmectite in size, weight, colour, smell, taste, and appearance, and was inert. Blinding seems appropriate. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blind review of data by outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | High risk | 40 children (13%) were non‐adherent, and the rest analysed as per protocol. |
Selective reporting (reporting bias) | Low risk | None detected. Registered trial |
Other bias | Low risk | No other biases detected. |