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. 2018 Apr 25;2018(4):CD011526. doi: 10.1002/14651858.CD011526.pub2
Methods Randomized controlled trial
Length of follow‐up: not stated
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
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
Outcomes Duration of diarrhoea (until first formed stool)
Stool output in g/kg in the first 72 hrs
Notes Location: Peru
Setting: urban
Cause of diarrhoea: rotavirus 22%. Other aetiologies not specified.
Source of funding: industry
Registration number: NCT00352716
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.