Kianifar 2009.
Methods | Randomized controlled trial; 1 centre Duration: 18 months, April 2006 to September 2007 |
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Participants | Inclusion criteria: inpatients; infants and children aged 6 to 36 months with acute non‐bloody, non‐bacterial diarrhoea (not defined) of less than 2 days' duration and moderate dehydration Exclusion criteria: severe dehydration, antibiotic consumption, severe vomiting, convulsion, inflammatory cells in stool samples Number completing study: 32/34 (94.1%) probiotic and 30/34 (88.2%) placebo; participants excluded because of poor compliance. |
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Interventions |
Start time for administration not stated. All children received IV fluid therapy, oral rehydration solution, and mother’s milk in breast‐feeding infants, or complementary food according to the patient's age. |
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Outcomes |
No adverse events attributed to probiotic. |
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Notes | Study location: Iran (low child and adult mortality) Cause of diarrhoea: non‐bloody, non‐bacterial diarrhoea (not defined) Nutritional status: not stated. Hydration status: all had moderate dehydration; severe dehydration excluded. Source of funding: grant from the Vice Chancellery for Research, Mashad University of Medical Sciences. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Random number table sequence |
Allocation concealment? | Unclear risk | Not described |
Blinding? All outcomes | Low risk | placebo sachets matched for size, shape, and volume of contents; physicians, nurses and parents were blinded to the treatment protocol. |
Incomplete outcome data addressed? All outcomes | High risk | Follow up < 90% in placebo group |