Real-World Evidence on a Diosmectite-Based Medical Device: Safety and Efficacy Outcome From Pediatricians and Gastroenterologists.

Background: Diarrhea, both acute and chronic, is a common gastrointestinal condition that significantly affects patients’ quality of life (QoL). Aim of the data collection: In this investigation, a diosmectite-based medical device (MD), was evaluated as part of Post-Marketing Surveillance (PMS) in compliance with European Medical Device Regulation 2017/745 (MDR). The objective was to assess its efficacy and safety in realworld clinical settings (Real-World Evidence, RWE). Material and method: The study comprised two distinct data sets: (A) aggregated data from pediatricians involving 1,558 pediatric patients with acute or chronic diarrhea, and (B) aggregated data from gastroenterologists concerning 743 patients with chronic-recurrent diarrhea. All data were provided in aggregate form by participating physicians, based on retrospective analysis of patient medical records. Results: In both RWE settings, the MD demonstrated effectiveness in improving stool consistency and reducing evacuation frequency within a few days of treatment, with excellent tolerability. Conclusions: These findings, consistent with existing literature on diosmectite, support the use of the product as a safe and effective therapeutic option for managing diarrhea in both pediatric and adult populations—particularly in acute cases, with promising utility in chronic-persistent diarrhea of different etiologies.