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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: 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
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
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
Notes Location: France
Setting: urban
Cause of diarrhoea: rotavirus 77%
Source of funding: not specified
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.