Investigators from multiple institutions conducted a randomized, double-blind, placebo-controlled trial to assess the effect of probiotics on the severity of acute gastroenteritis. Children aged 3 months to 4 years seen at 1 of 10 pediatric EDs were eligible if they had acute gastroenteritis, defined as ≥3 episodes of watery stools per day, with or without vomiting, for <7 days. Children were excluded if they were immunocompromised or had a gastrointestinal disorder. Demographics and clinical symptoms were collected at enrollment.
Participants were randomized to receive either Lactobacillus rhamnosus GG (at a dose of 1 × 1010 colony-forming units) or placebo orally twice daily for 5 days. Placebo was identical in appearance, texture, and flavor. Providers and participants were blinded to trial group assignment. Stool samples were obtained from all participants. Caregivers reported symptoms to the study team daily for 5 days, as well as at 14 days and 1 month. Caregivers also reported side effects, hours of missed work, and days of day care missed.
The primary outcome was moderate to severe gastroenteritis during 14 days of follow-up, defined as Vesikari scale scores of ≥9 (out of 20, with higher scores indicating higher severity) that were based on caregiver-reported symptoms. Secondary outcomes included duration of diarrhea and vomiting, days of day care missed, hours of missed work, and adverse events. Investigators conducted an intention-to-treat analysis. Subgroup analyses were also conducted by age (<1 or ≥1 year), duration of symptoms at presentation (<48 or ≥48 hours), and type of enteric pathogen.
There were 971 participants randomized, of whom 943 (97.1%) completed the trial. No significant demographic differences were observed between participants in each group except for race/ethnicity. There were no significant differences in stool sample results across groups, with the most common organism identified in each group being norovirus (18.3% vs 20.8% in placebo and probiotic groups, respectively).
There was no significant difference in severity of gastroenteritis at 14 days between groups (12.6% vs 11.8% of participants in placebo and probiotic groups with Vesikari scores of ≥9, respectively; P=.83). There were also no significant differences in this primary outcome among subgroups or in secondary outcomes between groups. There were no significant adverse events reported, though participants in the probiotic (vs control) group had significantly more wheezing (5 vs 0 participants in probiotic and control groups, respectively; P=.03).
The investigators conclude that treatment with 5 days of L rhamnosus GG is not associated with improvement in outcomes in children with gastroenteritis.
Dr Brady has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.
The results of 2 large, well-designed trials failed to support the use of probiotics for management of acute gastroenteritis in infants...