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. 2018 Apr 25;2018(4):CD011526. doi: 10.1002/14651858.CD011526.pub2
Methods Randomized controlled trial
Length of follow‐up: 5 days
Participants Number: 62 enrolled children
Inclusion criteria: inpatients; infants/children aged 1 to 24 months with acute secretory diarrhoea < 3 days duration, with 3 watery stools per day
Exclusion criteria: severe dehydration, third‐degree malnutrition, other medications, chronic illnesses
Breastfeeding: included
Interventions Intervention group: diosmectite. Dosage 1.5 g, every 12 hrs for infants < 3 kg; every 8 hrs for infants 4 to 10 kg; every 6 hrs for children 11 to 15 kg, for a maximum of 5 days
Control: no medication
Outcomes Duration of diarrhoea (from first intervention dose until last liquid stool)
Number of stools
Change in weight
Oral liquid intake
Notes Location: Thailand
Setting: urban
Cause of diarrhoea: rotavirus in 3% of children in intervention group, 19% in control group. Stool cultures were reported positive for Salmonella and Aeromonas spp. in 7% and 9% of children in the control and study group, respectively, but numbers of each bacterial aetiology per group were not stated.
Source of funding: industry
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Stated as randomized, but no method of randomization described. Selection bias is suspected as groups were different in the aetiology of diarrhoea.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
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 Low risk No children were lost to follow‐up
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement. No protocol registered.
Other bias Low risk No other biases were detected.