Abstract

Purpose: The aim of this study was to compare two adjunct therapies in the treatment of childhood rotavirus gastroenteritis (RVGE). We compared the recommended treatment, probiotic Lactobacillus reuteri DSM 17938 (BioGaia®), vs. a novel treatment, enterosorbent polymethylsiloxane polyhydrate (Enterosgel®).Methods: This was an open-label, randomized, clinical controlled trial at the University Hospital for Infectious Diseases (UHID) in Zagreb, Croatia. A total of 149 children aged 6–36 months with acute rotaviral gastroenteritis over a period of <48 h, with no significant chronic comorbidity, were randomized to receive the standard therapy with L. reuteri DSM 17938 (hereafter L. reuteri) or polymethylsiloxane polyhydrate (hereafter PMSPH) therapy, during 5 days. The primary end point was time to recovery in days in both groups. The recovery was defined as absence of fever and vomiting and either the first firm stool, absence of stool for more than 24 h, or return of usual bowel habit.Results: A total of 75 children were randomized into the L. reuteri group and 74 were randomized into the PMSPH group; after excluding missing data, the data from 65 children in each group were analyzed. There was no significant difference in the treatment efficacy between the two regimens with an estimated median time of recovery of 6 days in both groups (p = 0.754). No significant side effects were observed in either group.Conclusion: Novel enterosorbent PMSPH had a similar efficacy to probiotic L. reuteri in the treatment of rotaviral gastroenteritis in preschool children.Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT04116307 [October 3, 2019] (retrospectively registered). https://clinicaltrials.gov/show/NCT04116307.

Highlights

  • Rotavirus is the most frequent cause of acute gastroenteritis (AGE) in preschool children in countries without universal infant vaccination against rotavirus (RV) [1, 2]

  • A total of 149 children aged 6–36 months with acute rotaviral gastroenteritis over a period of

  • A total of 75 children were randomized into the L. reuteri group and 74 were randomized into the polymethylsiloxane polyhydrate (PMSPH) group; after excluding missing data, the data from 65 children in each group were analyzed

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Summary

Introduction

Rotavirus is the most frequent cause of acute gastroenteritis (AGE) in preschool children in countries without universal infant vaccination against rotavirus (RV) [1, 2]. Health insurance covers only the vaccination of the population at risk, such as children with heart defects, chronic kidney and liver diseases, metabolic illnesses, and severe brain damage. The reasons for such practice are purely financial. The guidelines of the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the European Society for Pediatric Infectious Diseases (ESPID) suggest that some probiotics can be considered for the treatment of gastroenteritis. These include the first-line probiotics Lactobacillus rhamnosus GG (LGG) and Saccharomyces boulardii. Lactobacillus reuteri DSM 17938 and Lactobacillus acidophilus LB are included in the list of recommended strains [12]

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