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. 2018 Apr 25;2018(4):CD011526. doi: 10.1002/14651858.CD011526.pub2
Methods Quasi‐randomized controlled trial
Length of follow‐up: 5 days
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
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
Outcomes Clinical resolution (return of stools to previous formed consistency and average number of frequency)
Stool output (g/kg)
Stool frequency
Notes Location: Egypt
Setting: urban
Cause of diarrhoea: rotavirus 43%, bacterial (not specified) 23%
Source of funding: not specified
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.