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

Kianifar 2009.

Methods Randomized controlled trial; 1 centre
Duration: 18 months, April 2006 to September 2007
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.
Interventions
  1. Live L. acidophilus 3 x 109 and Bifidobacterium bifidum 3 x 109 /day for 5 days (Infloran; Laboratorio Farmaceutico SIT S.r.I., Mede, Pavia, Italy) in 5–10 mL of water

  2. placebo (maltodextran)


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.
Outcomes
  1. Duration of diarrhoea

  2. Reduction in defecation frequency

  3. Weight gain

  4. Duration of hospital admission


No adverse events attributed to probiotic.
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.
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