Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations

doi:10.1136/bmj.39272.581736.55

BMJ, doi: 10.1136/bmj.39272.581736.55, (Published 9 August 2007)

Research

Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations

Roberto Berni Canani, assistant professor of paediatrics¹, Pia Cirillo, paediatrician¹, Gianluca Terrin, paediatrician¹, Luisa Cesarano, paediatrician¹, Maria Immacolata Spagnuolo, paediatrician¹, Anna De Vincenzo, paediatrician¹, Fabio Albano, paediatrician¹, Annalisa Passariello, paediatrician¹, Giulio De Marco, paediatrician¹, Francesco Manguso, consultant physician in gastroenterology², Alfredo Guarino, professor of paediatrics¹

¹ Department of Paediatrics, University of Naples Federico II, Naples, Italy, ² Department of Clinical and Experimental Medicine, University of Naples Federico II

Correspondence to: A Guarino alfguari{at}unina.it

Objective To compare the efficacy of five probiotic preparationsrecommended to parents in the treatment of acute diarrhoea inchildren.

Design Randomised controlled clinical trial in collaborationwith family paediatricians over 12 months.

Setting Primary care.

Participants Children aged 3-36 months visiting a family paediatricianfor acute diarrhoea.

Intervention Children's parents were randomly assigned to receivewritten instructions to purchase a specific probiotic product:oral rehydration solution (control group); Lactobacillus rhamnosusstrain GG; Saccharomyces boulardii; Bacillus clausii; mix ofL delbrueckii var bulgaricus, Streptococcus thermophilus, Lacidophilus, and Bifidobacterium bifidum; or Enterococcus faeciumSF68.

Main outcome measures Primary outcomes were duration of diarrhoeaand daily number and consistency of stools. Secondary outcomeswere duration of vomiting and fever and rate of admission tohospital. Safety and tolerance were also recorded.

Results 571 children were allocated to intervention. Medianduration of diarrhoea was significantly shorter (P<0.001)in children who received L rhamnosus strain GG (78.5 hours)and the mix of four bacterial strains (70.0 hours) than in childrenwho received oral rehydration solution alone (115.0 hours).One day after the first probiotic administration, the dailynumber of stools was significantly lower (P<0.001) in childrenwho received L rhamnosus strain GG and in those who receivedthe probiotic mix than in the other groups. The remaining preparationsdid not affect primary outcomes. Secondary outcomes were similarin all groups.

Conclusions Not all commercially available probiotic preparationsare effective in children with acute diarrhoea. Paediatriciansshould choose bacterial preparations based on effectivenessdata.

Trial registration number Current Controlled Trials ISRCTN56067537 [controlled-trials.com] .

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