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

BMJ 2007; 335 doi: (Published 16 August 2007) Cite this as: BMJ 2007;335:340
  1. Roberto Berni Canani, assistant professor of paediatrics1,
  2. Pia Cirillo, paediatrician1,
  3. Gianluca Terrin, paediatrician1,
  4. Luisa Cesarano, paediatrician1,
  5. Maria Immacolata Spagnuolo, paediatrician1,
  6. Anna De Vincenzo, paediatrician1,
  7. Fabio Albano, paediatrician1,
  8. Annalisa Passariello, paediatrician1,
  9. Giulio De Marco, paediatrician1,
  10. Francesco Manguso, consultant physician in gastroenterology2,
  11. Alfredo Guarino, professor of paediatrics1
  1. 1Department of Paediatrics, University of Naples Federico II, Naples, Italy
  2. 2Department of Clinical and Experimental Medicine, University of Naples Federico II
  1. Correspondence to: A Guarino alfguari{at}
  • Accepted 18 June 2007


Objective To compare the efficacy of five probiotic preparations recommended to parents in the treatment of acute diarrhoea in children.

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

Setting Primary care.

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

Intervention Children's parents were randomly assigned to receive written instructions to purchase a specific probiotic product: oral rehydration solution (control group); Lactobacillus rhamnosus strain GG; Saccharomyces boulardii; Bacillus clausii; mix of L delbrueckii var bulgaricus, Streptococcus thermophilus, L acidophilus, and Bifidobacterium bifidum; or Enterococcus faecium SF68.

Main outcome measures Primary outcomes were duration of diarrhoea and daily number and consistency of stools. Secondary outcomes were duration of vomiting and fever and rate of admission to hospital. Safety and tolerance were also recorded.

Results 571 children were allocated to intervention. Median duration 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 children who received oral rehydration solution alone (115.0 hours). One day after the first probiotic administration, the daily number of stools was significantly lower (P<0.001) in children who received L rhamnosus strain GG and in those who received the probiotic mix than in the other groups. The remaining preparations did not affect primary outcomes. Secondary outcomes were similar in all groups.

Conclusions Not all commercially available probiotic preparations are effective in children with acute diarrhoea. Paediatricians should choose bacterial preparations based on effectiveness data.

Trial registration number Current Controlled Trials ISRCTN56067537.


  • We are grateful to Jean Ann Gilder for editing the text. The research was not sponsored by any pharmaceutical or food company, including yoghurt companies.

  • Contributors: RBC and AG designed the study, coordinated the research team, and wrote the first draft of the report. PC, FA, LC, MIS, ADeV, and AP cared for the patients and contributed to the final version of the report. GDeM and GT performed the data analysis and FM contributed to the design of the study, developed the computer generated randomisation list, and performed statistical analyses. AG is guarantor.

  • Competing interests: None declared.

  • Funding: None.

  • Ethical approval: Ethics committee of University of Naples Federico II.

    Provenance and peer review: Non-commissioned; externally peer reviewed

  • Accepted 18 June 2007
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