Methods | Randomized controlled trial Length of follow‐up: 5 days |
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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 |
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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 |
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Outcomes | Duration of diarrhoea (from first intervention dose until last liquid stool) Number of stools Change in weight Oral liquid intake |
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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 |
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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. |