Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2007 Aug 18;335(7615):340.
doi: 10.1136/bmj.39272.581736.55. Epub 2007 Aug 9.

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

Roberto Berni Canani  1 , Pia Cirillo, Gianluca Terrin, Luisa Cesarano, Maria Immacolata Spagnuolo, Anna De Vincenzo, Fabio Albano, Annalisa Passariello, Giulio De Marco, Francesco Manguso, Alfredo Guarino
Affiliations
Randomized Controlled Trial

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

Roberto Berni Canani et al. BMJ. .

Abstract

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 [controlled-trials.com].

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Funding: None.

Figures

None
Flow of participants through trial of probiotic preparations for treatment of childhood acute diarrhoea
See this image and copyright information in PMC

Comment in

References

    1. Alam NH, Ashraf H. Treatment of infectious diarrhea in children. Paediatr Drugs 2003;5:151-65. - PubMed
    1. Szajewska H, Setty M, Mrukowicz J, Guandalini S. Probiotics in gastrointestinal diseases in children: hard and not-so-hard evidence of efficacy. J Pediatr Gastroenterol Nutr 2006;42:454-75. - PubMed
    1. Isolauri E. Probiotics for infectious diarrhoea. Gut 2003;52:436-7. - PMC - PubMed
    1. Davidson GP, Butler RN. Probiotics in intestinal disorders. Curr Opin Pediatr 2000;12:477-81. - PubMed
    1. Saavedra JM, Bauman NA, Oung I, Perman JA, Yolken RH. Feeding of Bifidobacterium bifidum and Streptococcus thermophilus to infants in hospital for prevention of diarrhoea and shedding of rotavirus. Lancet 1994;344:1046-9. - PubMed

Publication types

Associated data