The Journal of Clinical Medicine

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

Correspondence to Author: Miriam Concas1, Andrea Mosaico2, Sofia Pallante3,Pasquale Pezzella1, Gianfranco Trapani5,Gianfranco Trapani2,Stefania Colombo6,Daria Sicari6,Ilaria Carnevali 6. 

1. Pediatrician, Mediocampidano South Sardinia;
2. Gastroenterologist, Azienda Usl Tosaca Nord Ovest;
3. Pediatrician, Rome (RM);
4. Gastroenterologist, Naples (NA);
5. Pediatrician, Nutrition Expert, Sanremo (IM);
6. Scientific Medical Direction PharmaLine s.r.l. Milan (MI), Italy

DOI: 10.52338/jotr.2025.5013

Abstract:

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.

Keywords: Acute Diarrhea, Chronic Diarrhea, Diosmectite, Pediatric, Gastroenterology.

Citation:

Dr.Daria Sicari, Real-World Evidence on a Diosmectite-Based Medical Device: Safety and Efficacy Outcome From Pediatricians and Gastroenterologists. The Journal of Clinical Medicine 2025.

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