Lactobacillus reuteri protectis DSM 17938 at high doses versus placebo in children with acute gastroenteritis in a Pediatric Emergency Department

Abstract Introduction Acute gastroenteritis (AGE) is a frequent cause of infant morbidity and mortality. There are many adjuvants therapeutic strategies for treatment, including probiotics, however, their efficacy is still debated. Objectives To assess the efficacy of the strain Lactobacillus reuteri DSM 17938 adjunct to oral rehydration therapy (ORT) in the treatment of children with AGE. Methods Randomized, controlled, double‐blind, clinical trial conducted in a pediatric emergency department (PED) from October 2021 to January 2023. Children between 1 and 60 months of age with AGE, absence of or mild to moderate dehydration, were included. Clinical and management characteristics were recorded. Results Sixty‐two patients in L. reuteri (group 1) and seventy patients in the placebo group (group 2) were included. Group 1 had less duration of diarrhea (2.77 ± 0.6 vs. 3.10 ± 1.1 days; p = 0.036). The mean frequencies of watery diarrhea in group 1 versus 2 on Days 2, 3, 4, and 5 were less in group 1. Watery diarrhea persisted in 58.6% in group 2 and in 19.4% of group 1 at 5 days of treatment. Conclusions This study shows that L. reuteri DSM 17938 is effective in decreasing frequency and consistency of stools; and is safe at high doses in patients from 1 month to 5 years of age, in emergency management. It is a low‐risk and easy‐to‐administer intervention, which could reduce complications associated with losses due to AGE.