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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: 56 enrolled children
Inclusion criteria: inpatients; children aged 2 to 24 months with moderate‐to‐severe acute diarrhoea
Exclusion criteria: malnutrition
Breastfeeding: not specified
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.
Outcomes Duration of diarrhoea (time to normalization of stools)
Stool frequency on day 5
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
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.