Presentation (CTI)

OBJECTIVES: Community pharmacies represent a key setting for conducting prospective observational studies, acting as a primary access point for individuals engaging in self-care and immediate symptom management. In Italy, this context has proven feasible for enrolling self-medicating patients and collecting real-world data, including patient-reported outcomes (PROs), within routine practice. The FLORA study builds on this framework in the gastrointestinal (GI) field, focusing on individuals with acute GI symptoms who autonomously initiate probiotic supplementation with Lacticaseibacillus paracasei DG (LpDG) in community pharmacies, enabling standardized, scalable real-world evidence generation.
METHODS: The study design integrates key components including the use of a standardized protocol for data collection and analysis, recruitment through a qualified network of pharmacies affiliated with the Italian Society of Clinical Pharmacy (SIFAC), regulatory submission to Ethics Committee in line with national requirements, structured training of participating pharmacists, and centralized data management and analysis. Within this framework, FLORA is implemented as a multicentre, prospective, observational cohort study conducted in 20 Italian community pharmacies, selected nationwide to ensure representativeness. Currently, 300 adults with acute GI symptoms who independently initiate probiotic supplementation with LpDG are being enrolled over a 4-month window. Self-reported information is collected via online-based questionnaires and validated ePROs - the Gastrointestinal Symptom Rating Scale and Short Form-12 - over a 14-day follow-up.
RESULTS: This design enables systematic patient-level data collection at the point of self-care. By integrating evidence generation into routine patient behavior and leveraging community pharmacies as a primary point of contact for individuals initiating probiotic therapy, FLORA effectively bridges critical evidence gaps on the real‑world use of LpDG, delivering richer and more actionable insights into treatment patterns and patient outcomes in everyday clinical practice.
CONCLUSIONS: FLORA demonstrates the practical application of an innovative framework for real-world evidence generation, offering a scalable model to assess self-care practices and patient-reported outcomes in everyday practice.