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.