Systematic Review With Meta-Analysis

Lactobacillus Rhamnosus GG for Treating Acute Gastroenteritis in Children

A 2019 Update

Hania Szajewska; Maciej Kołodziej; Dorota Gieruszczak-Białek; Agata Skórka; Marek Ruszczyński; Raanan Shamir


Aliment Pharmacol Ther. 2019;49(11):1376-1384. 

In This Article

Abstract and Introduction


Background: Recently, evidence from a large randomised controlled trial (RCT) negated efficacy of Lactobacillus rhamnosus GG for treating acute gastroenteritis in children.

Aim: To review RCTs in which L rhamnosus GG was used to treat acute gastroenteritis in children.

Methods: The Cochrane Library, MEDLINE, and EMBASE databases were searched from May 2013 (end of last search) to January 2019. The primary outcomes were stool volume and duration of diarrhoea.

Results: Eighteen RCTs (n = 4208) were included. Compared with placebo or no treatment, L rhamnosus GG use had no effect on stool volume but was associated with a reduced duration of diarrhoea (15 RCTs, n = 3820, mean difference, MD −0.85 day, 95% CI −1.15 to −0.56). L rhamnosus GG was effective when used at a daily dose of ≥1010 CFU or <1010 CFU; however, the latter produced results of borderline significance. L rhamnosusGG was more effective when used in European countries compared with non-European countries, particularly when considered by region. L rhamnosus GG use was associated with a reduced duration of hospitalisation. One RCT found that L rhamnosus GG had no effect on the total clinical severity score at 14 days after enrolment.

Conclusions: Despite a recent large RCT demonstrating no effect of L rhamnosus GG, current evidence shows that, overall, L rhamnosus GG reduced both the duration of diarrhoea (with a higher impact in European countries) and hospitalisation in inpatients. These findings should be viewed in the context of the high heterogeneity and methodological limitations of the included trials.


Acute gastroenteritis continues to be a leading cause of death in children younger than 5 years of age in deprived areas and a leading cause of morbidity worldwide.[1] Furthermore, acute gastroenteritis results in a high rate of hospitalisation, and it is associated with an economic burden inflicted by parents' absence from work.[2] In 2014, the European Society for Paediatric Gastroenterology, Hepatology and Nutrition published its guidelines for the management of acute gastroenteritis in children and concluded that 'the use of the following probiotics (in alphabetical order) may be considered in the management of children with acute gastroenteritis in addition to rehydration therapy: Lactobacillus rhamnosus GG (low quality of evidence, strong recommendation) and Saccharomyces boulardii (low quality of evidence, strong recommendation).'[2] At that time, based on the findings from our 2013 meta-analysis of randomised controlled trials (RCTs),[3] the evidence for L rhamnosus GG included that its administration during acute gastroenteritis, at a dose of ≥1010 colony-forming units (CFU)/day, reduced the duration of diarrhoea in all patients (ambulatory and hospitalised) in geographical Europe. Nevertheless, as reflected by the low quality of evidence, the recommendation was that the evidence should be viewed with caution. Similar conclusions were reached by some other organisations or experts.[4,5]

Recently, a large, prospective RCT carried out in the USA, including 971 children aged 3 months to 4 years, compared the administration of L rhamnosus GG at a dose of 1 x 1010 CFU twice daily to a matching placebo over 5 days and found no differences in outcomes, including duration of diarrhoea and day care absence, between groups.[6] Similarly, no difference between groups in duration of diarrhoea was observed in another RCT performed in Canada in which 886 children aged 3-48 months received a combination probiotic product containing L rhamnosus R0011 (which is similar to L rhamnosus GG but differs in pilus gene clusters; thus, the two strains produce different functional pili) and L helveticus R0052, at a dose of 4.0×109 CFU twice daily, or placebo over 5 days.[7] As the conclusion of these high impact publications was that L rhamnosus GG (or a combination probiotic product including a similar strain to L rhamnosus GG) is not efficacious in the treatment of acute gastroenteritis, our aim was to systematically update our 2013 meta-analysis on the effectiveness of L rhamnosus GG in treating acute gastroenteritis in children. The intention is that this updated meta-analysis will serve as a basis for revising the guidelines for the management of acute gastroenteritis in children.