Efficacy and safety of Limosilactobacillus reuteri DSM 17938 for the treatment of acute gastroenteritis in children: a systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION: Acute gastroenteritis (AGE) remains a major global clinical concern in pediatric populations. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Limosilactobacillus reuteri DSM 17938 for the treatment of acute gastroenteritis in children, with the duration of diarrhea as the primary outcome. METHODS: A comprehensive literature search was conducted across MEDLINE (via PubMed), Embase, Scopus, and the Science Citation Index Expanded from inception to April 1, 2026. Two independent reviewers performed study selection, data extraction, and risk of bias assessment using the Cochrane RoB 2 tool. Random-effects models pooled mean differences (MD) and risk ratios (RR), and the certainty of the evidence was appraised via the GRADE approach. RESULTS: Six randomized controlled trials involving 565 randomized children (527 analyzed for the primary outcome) met the inclusion criteria. Limosilactobacillus reuteri DSM 17938 significantly reduced the duration of diarrhea by a mean difference of 0.68 days (95% CI: -1.09 to -0.27). Furthermore, the persistence of diarrhea was significantly lower in the probiotic group at 48 hours (RR 0.45, 95% CI 0.29 to 0.69) and 72 hours (RR 0.41, 95% CI 0.23 to 0.72). No serious or treatment-related adverse events were reported across the trials. The certainty of the evidence was rated as very low for diarrhea duration and low for persistence at 48-72 hours due to high heterogeneity and risk of bias concerns. DISCUSSION: Limosilactobacillus reuteri DSM 17938 produces a modest reduction in the duration of diarrhea and a substantial decrease in persistence at 48-72 hours, accompanied by a favorable safety profile. However, due to the very low certainty of the evidence regarding the primary outcome, these findings should be interpreted with caution in clinical practice. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD420261449562, PROSPERO CRD420261449562.