Methods | Randomized controlled trial Length of follow‐up: until recovery from diarrhoea |
|
Participants | Number: 90 enrolled children Inclusion criteria: inpatients; well‐nourished male children aged 3 to 24 months with watery diarrhoea < 5 days duration, with dehydration of any severity Exclusion criteria: prolonged diarrhoea, malnutrition, major illnesses Breastfeeding: not specified |
|
Interventions | Intervention group: diosmectite. Dosage 1.5 g, 4 times daily for 3 days Control group: placebo |
|
Outcomes | Duration of diarrhoea (from enrolment to last liquid stool) Frequency of diarrhoea Duration of vomiting Feeding pattern |
|
Notes | Location: Egypt Setting: urban Cause of diarrhoea: rotavirus 16%. Other aetiologies not specified. Source of funding: WHO and industry |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomization by Diarrheal Disease Control Programme of the WHO |
Allocation concealment (selection bias) | Low risk | Numerically coded envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Use of placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Use of placebo |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement. No protocol registered. |
Other bias | Low risk | No other biases detected. |