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


METHODS
Primary care.


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


METHODS
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.


METHODS
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.


BACKGROUND
Current Controlled Trials ISRCTN56067537 [controlled-trials.com].
Canani
Roberto Berni
RB
Department of Paediatrics, University of Naples Federico II, Naples, Italy.
Cirillo
Pia
P
Terrin
Gianluca
G
Cesarano
Luisa
L
Spagnuolo
Maria Immacolata
MI
De Vincenzo
Anna
A
Albano
Fabio
F
Passariello
Annalisa
A
De Marco
Giulio
G
Manguso
Francesco
F
Guarino
Alfredo
A
D000208:Acute Disease; D002675:Child, Preschool; D003967:Diarrhea / Q000628:therapy*; D006801:Humans; D007223:Infant; D019936:Probiotics / Q000627:therapeutic use*; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
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