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Randomized Controlled Trial
. 2015 Jan 14;5(1):e006474.
doi: 10.1136/bmjopen-2014-006474.

Can Probiotic Yogurt Prevent Diarrhoea in Children on Antibiotics? A Double-Blind, Randomised, Placebo-Controlled Study

Free PMC article
Randomized Controlled Trial

Can Probiotic Yogurt Prevent Diarrhoea in Children on Antibiotics? A Double-Blind, Randomised, Placebo-Controlled Study

Michael J Fox et al. BMJ Open. .
Free PMC article


Objective: To estimate the efficacy of a probiotic yogurt compared to a pasteurised yogurt for the prevention of antibiotic-associated diarrhoea in children.

Design and setting: This was a multisite, randomised, double-blind, placebo-controlled clinical trial conducted between September 2009 and 2012. The study was conducted through general practices and pharmacies in Launceston, Tasmania, Australia.

Participants and interventions: Children (aged 1-12 years) prescribed antibiotics, were randomised to receive 200 g/day of either yogurt (probiotic) containing Lactobacillus rhamnosus GG (LGG), Bifidobacterium lactis (Bb-12) and Lactobacillus acidophilus (La-5) or a pasteurised yogurt (placebo) for the same duration as their antibiotic treatment.

Outcomes: Stool frequency and consistency were recorded for the duration of treatment plus 1 week. Primary outcome was stool frequency and consistency, classified at different levels of diarrhoea severity. Due to the small number of cases of diarrhoea, comparisons between groups were made using Fisher's exact analysis.

Results: 72 children commenced and 70 children (36 placebo and 34 probiotic) completed the trial. There were no incidents of severe diarrhoea (stool consistency ≥6, ≥3 stools/day for ≥2 consecutive days) in the probiotic group and six in the placebo group (Fisher's exact p=0.025). There was also only one episode of minor diarrhoea (stool consistency ≥5, ≥2 stools/day for ≥2 days in the probiotic group compared to 21 in the placebo group (Fisher's exact p<0.001). The probiotic group reported fewer adverse events (1 had abdominal pain, 1 vomited and 1 had headache) than the placebo group (6 had abdominal pain, 4 had loss of appetite and 1 had nausea).

Conclusions: A yogurt combination of LGG, La-5 and Bb-12 is an effective method for reducing the incidence of antibiotic-associated diarrhoea in children.

Trial registration number: Australian New Zealand Clinical Trials Registry ACTRN12609000281291.



Figure 1
Figure 1
Proportion of children at risk for the first occurrence of (A) stool consistency score of ≥6; and (B) stool frequency of ≥3 stools a day. Stool consistency of 6 corresponds to fluffy pieces with ragged edges of loose mushy stool based on the Bristol Stool Scale. The solid line represents the placebo group and the dashed line represents the probiotic group.

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