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document
Randomised clinical trial : efficacy of a new synbiotic formulation containing Lactobacillus paracasei B21060 plus arabinogalactan and xilooligosaccharides in children with acute diarrhoea . BACKGROUND Acute diarrhoea is a frequent problem in children with heavy economic burden for families and society . AIM To test the efficacy of a new synbiotic formulation containing Lactobacillus paracasei B21060 , arabinogalactan and xilooligosaccharides in children with acute diarrhoea . METHODS Double-blind , randomised , placebo-controlled trial , including children ( age 3-36 m ) with acute diarrhoea who were allocated to placebo or synbiotic group . Major outcome was resolution rate of diarrhoea at 72 h. Total duration of diarrhoea , daily stool outputs , stool consistency , working days lost by parents , adjunctive medications , and hospitalisation were also assessed . RESULTS We enrolled 55 children in placebo group and 52 in synbiotic group . The two groups were similar for demographic and clinical characteristics . Resolution rate of diarrhoea at 72 h was significantly higher in synbiotic group ( 67 % ) compared to placebo group ( 40 % , P = 0.005 ) . Children in synbiotic group showed a significant reduction in the duration of diarrhoea ( 90.5 h , 78.1-102.9 vs. 109.8 h , 96.0-123.5 , P = 0.040 ) , daily stool outputs ( 3.3 , 2.8-3.8 vs. 2.4 , 1.9-2.8 , P = 0.005 ) and stool consistency ( 1.3 , 0.9-1.6 vs. 0.6 , 0.4-0.9 , P = 0.002 ) compared to placebo group ( data expressed as mean , 95 % CI ) . Rate of parents that missed at least one working day ( 41.8 % vs. 15.4 % , P = 0.003 ) , rate of children that needed adjunctive medications ( 25.5 % vs. 5.8 % , P = 0.005 ) or hospitalisation ( 10.9 % vs. 0 % , P = 0.014 ) after the first 72 h of treatment , were reduced in synbiotic group . CONCLUSION The synbiotic formulation studied is effective in children with acute diarrhoea . Australian New Zealand Clinical Trials Registry ( ACTRN12611000641998 ) .
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Intervention_Pharmacological
synbiotic formulation containing Lactobacillus paracasei B21060 plus arabinogalactan and xilooligosaccharides
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Intervention_Pharmacological
synbiotic formulation containing Lactobacillus paracasei B21060 , arabinogalactan and xilooligosaccharides
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Intervention_Control
placebo
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Intervention_Control
synbiotic group
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Intervention_Control
placebo
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Intervention_Pharmacological
synbiotic
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Intervention_Control
placebo
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Intervention_Control
placebo
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Intervention_Pharmacological
synbiotic formulation
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Outcome_Other
efficacy
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Outcome_Physical
resolution rate of diarrhoea at 72 h.
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Outcome_Physical
duration of diarrhoea ,
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Outcome_Mental
daily stool outputs
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Outcome_Physical
,
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Outcome_Mental
stool consistency
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Outcome_Physical
,
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Outcome_Mental
working days lost by parents
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Outcome_Other
adjunctive medications
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Outcome_Other
hospitalisation
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Outcome_Adverse-effects
Resolution rate of diarrhoea
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Outcome_Adverse-effects
duration of diarrhoea
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Outcome_Mental
daily stool outputs
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Outcome_Mental
stool consistency
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Outcome_Other
Rate of parents that missed at least one working day
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Outcome_Other
rate of children that needed adjunctive medications
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Outcome_Other
hospitalisation
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Participant_Condition
acute diarrhoea
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Participant_Condition
acute diarrhoea
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Participant_Age
age 3-36 m
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Participant_Sample-size
55 children in placebo group
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Participant_Sample-size
52 in synbiotic group