Lee 2001.
Methods | Randomized controlled trial, non‐blinded; 1 centre Duration: 6 months, October 1999 to March 2000 |
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Participants | Inclusion criteria: inpatients; consecutive admissions aged 6‐60 months; diarrhoea < 5 days and > 3 watery stools in last 24 hours. Average dehydration about 5% in both groups. Exclusion criteria: bloody stools, antidiarrhoeal or antiperistaltic drugs; children receiving lactose‐free, protein hydrolysated formula for malabsorptive disorder; compromised immune system. Number completing study: 50/50 (100%) probiotic and 50/50 (100%) control group. |
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Interventions |
All children had IV fluids because of vomiting. Interventions administered after initial fluid therapy. |
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Outcomes |
No comment regarding adverse effects. |
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Notes | Study location: Taiwan (low child and adult mortality). Cause of diarrhoea: bloody diarrhoea excluded. Nutritional status: no data presented. Hydration status: % average dehydration 4.3 (SD 1.5) in probiotic and 4.0 (1.4) in control group. Source of funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Not described |
Allocation concealment? | Unclear risk | Not described |
Blinding? All outcomes | Unclear risk | Probably open study; no placebo |
Incomplete outcome data addressed? All outcomes | Low risk | Follow up ≥ 90% in both groups |