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. 2010 Nov 10;2010(11):CD003048. doi: 10.1002/14651858.CD003048.pub3

Lee 2001.

Methods Randomized controlled trial, non‐blinded; 1 centre
Duration: 6 months, October 1999 to March 2000
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.
Interventions
  1. Lyophilized L. acidophilus and Bifidobacteria infantis (Infloran Berna; 3 x 109 of each organism/day for 4 days)

  2. No additional treatment


All children had IV fluids because of vomiting. Interventions administered after initial fluid therapy.
Outcomes
  1. Stool frequency by day of intervention

  2. Duration of diarrhoea (time until the last watery stool)

  3. Recovery rate on day 2


No comment regarding adverse effects.
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
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