ירחון החברה הישראלית לפדיאטריה אמבולטורית (חיפ"א) גיליון 2019-1

36 Are Probiotics Effective Treatment for Gastroenteritis? Probiotics are routinely recommended for alleviating the symptoms of and shortening the course of gastroenteritis. However, in the November 22, 2018 issue of the New England Journal of Medicine, two very similar randomized, double-blinded, placebo- controlled trials, one from Canada and one from the United States, brought this common practice into question. Both studies including a total of 1857 children aged 3 month to 4 years old who presented to a pediatric emergency department with acute gastroenteritis. Both studies were similar in design, endpoint and results – with the primary result being any moderate-severe gastroenteritis within 14 days of initiation of probiotics. Both used L. rhamnosus, though the Canadians added L. helveticus. The American study utilized 10 pediatric emergency centers in the PECARN network, providing a diverse multi-centered population. Over 900 participants were randomized to receive placebo or 1x1010 CFU twice daily for 5 days and were followed for 14 days. Severity of the illness, as measured by a Modified Vesikari Scale, was similar in the 2 groups, with moderate to severe illness occurring in 11.8% of trial group vs 12.6% in the placebo group. There were also no significant differences in duration (mean 49.7 vs 50.9 hrs. p=0.26), day care absenteeism (median=2 days both groups, p=0.67) or rate of household transmission (10.6 vs 14.1% p=0.16). The Canadians enrolled 886 children from 6 pediatric EDs in the PERC network, providing 4.0 x 109 CFU twice daily to the trial group. Their patients experienced higher rates of severity, but also, similar in both the trial and control group (26.1% vs 24.7%, respectively, p=0.72), and little difference in duration (52.5 vs 55.5 hrs. p=0.31) and vomiting (17.7 vs 18.7hrs. p=0.18), nor for unscheduled doctor visits (30.2% vs 26.6% p=0.27). These trials damper the perceived effect of and benefit of probiotics and are more vigorous than previous smaller studies. However, I am not convinced. For one, the studies are limited to (primarily) one strain of probiotics, albeit, one that has shown efficacy for a variety of illnesses in previous studies. Secondly, there is significant rates of severity between the two groups – and the America cohort is had mod-severe rates significantly lower than the rate of 25% that they had predicted.