Clinical Question

Is the probiotic Lactobacillus rhamnosus GG safe and effective for the treatment of acute gastroenteritis in young children?

Bottom Line

Treatment with the probiotic L. rhamnosus GG does not result in faster symptomatic improvement or less moderate or severe diarrhea in young children with acute gastroenteritis. (Level of Evidence = 1b)

Synopsis

Although some studies have shown a benefit to probiotics for the treatment of acute gastroenteritis in children, they have generally been small, funded by industry, or had methodologic flaws. This study was a large, well-designed randomized trial that attempted to more definitively answer this question. Children three months to four years of age with at least three watery stools per day for less than seven days were identified in 10 university pediatric emergency departments. Children were excluded if they or their caregivers were potentially immunocompromised, or if the children were taking long-term corticosteroids, had been premature, or had chronic gastrointestinal disease. Children were also excluded if they had any biliary tract disease, hematochezia, or allergies to the study medication or to any antibiotics used to treat invasive L. rhamnosus infection. They were then randomized to receive the probiotic or placebo once daily for five days, stratified by presentation within or later than 48 hours of the onset of illness, and with the first dose given in the emergency department. Of the 971 patients randomized, 943 completed the study, with a similar rate of loss to follow-up in both groups. The median age of participants was 1.4 years, 53% were male, and the median duration of diarrhea was 53 hours; groups were balanced at the start of the study. After 14 days, the likelihood of moderate to severe symptoms based on the modified Vesikari scale score was similar between groups (11.8% in the probiotic group and 12.6% in the placebo group). There were also no differences between groups regarding secondary symptom outcomes such as the duration or frequency of diarrhea. There was more wheezing in the probiotic group (5 vs. 0; P = .03).

Study design: Randomized controlled trial (double-blinded)

Funding source: Government

Allocation: Concealed

Setting: Emergency department

Reference: Schnadower D, Tarr PI, Casper TC, et al. Lactobacillus rhamnosus GG versus placebo for acute gastroenteritis in children. N Engl J Med. 2018;379(21):2002–2014.

Editor's Note: Dr. Ebell is Deputy Editor for Evidence- Based Medicine for AFP and cofounder and Editor-in-Chief of Essential Evidence Plus.