Preschool-aged children with acute gastroenteritis did not experience significantly better outcomes with Lactobacillus rhamnosus GG treatment compared with placebo, according to a study published in The New England Journal of Medicine.
A group of investigators conducted a prospective, randomized, double-blind trial (Impact of Emergency Department Probiotic [LGG] Treatment of Pediatric Gastroenteritis, ClinicalTrials.gov Identifier: NCT01773967) to assess the efficacy of a probiotic to treat pediatric gastroenteritis in children aged 3 months to 4 years.
The primary outcome measured was moderate to severe gastroenteritis, defined as an episode of illness with a Vesikari scale–modified total score of 9 or higher, within 14 days following enrollment in a 5-day course of either L rhamnosus GG at a dosage of 1×1010 colony-forming units twice daily or an equivalently dosed placebo. Secondary outcomes included the frequency and duration of diarrhea and vomiting, duration of absence from daycare, and household transmission rate, defined as symptom development in household contacts who were previously asymptomatic.
Of 971 eligible participants, 943 completed the trial (median age, 1.4 years; 513 boys); 468 children were randomly assigned to the L rhamnosus GG cohort, and 475 were in the placebo cohort.
Of the members of the L rhamnosus GG and placebo groups, 55 children and 60 children, respectively, had a modified Vesikari scale score of 9 or higher for the 14 days following study enrollment (relative risk, 0.96).
For the L rhamnosus GG and placebo groups, no significant differences were noted in duration of diarrhea (median 49.7 hours vs 50.9 hours, respectively), duration of vomiting (median 0 hours for both groups), days absent from daycare (median 2 days for both groups), or household transmission rates (43 and 59, respectively).
“Treatment with L rhamnosus GG did not result in a smaller proportion of participants having moderate to severe gastroenteritis and failed to show benefit with respect to the duration or frequency of vomiting or diarrhea, the rate of household transmission, or the duration of daycare or work absenteeism,” concluded the authors.
Schnadower D, Tarr PI, Casper TC, et al. Lactobacillus rhamnosus GG versus placebo for acute gastroenteritis in children. N Engl J Med. 2018;379:2002-2014.