A Pre-Market, Two-Stages Interventional Clinical Investigation To Evaluate The Safety and The Performance of Fibroin Syrup In Reducing The Gastroesophageal Reflux Symptomatology In Non-Erosive Reflux Disease (NERD) Patients

Background/Objectives: Non-erosive reflux disease (NERD) is the most common pheno-type of gastroesophageal reflux disease (GERD) and is frequently characterized by persis-tent symptoms despite standard acid-suppressive therapy. Concerns regarding long-term proton pump inhibitor (PPI) use have increased interest in non-pharmacological ap-proaches capable of providing mechanical protection against refluxate while supporting mucosal repair. A novel oral medical device combining hyaluronic acid (HA) and silk fi-broin (SF) has been developed for this purpose. The product shows interesting bioadhesive properties and forms a solid gel when exposed at pH below 3. Methods: This pre-market, adaptive, two-stage interventional clinical investigation evaluated the safety and perfor-mance of an HA- and fibroin-based medical device (Fibroin Syrup) in adult subjects with symptomatic NERD. Following an initial pilot safety phase, the pivotal stage enrolled 47 adults with typical reflux symptoms lasting ≥8 weeks and absence of erosive esophagitis at upper endoscopy. Subjects received the investigational device for 6 weeks and were fol-lowed for 12 weeks. Gastroesophageal symptoms were assessed using the Reflux Disease Questionnaire (RDQ). The primary endpoint was the change in RDQ total score from base-line to the end of treatment. Safety was assessed through adverse event (AE) monitoring, physical examination, and vital signs. Results: All enrolled subjects completed the study and were included in safety and efficacy analyses. A significant reduction in GERD symp-toms was observed after 6 weeks of treatment, with a 65.2% median decrease in RDQ total score compared with baseline (p < 0.0001). Symptom improvement was maintained at fol-low-up (p < 0.001). RDQ frequency and severity sub-scores also showed statistically signif-icant reductions at all post-baseline visits (p < 0.001). Treatment satisfaction was high, with 95.7% of subjects reporting moderate-to-high satisfaction. The device demonstrated a favorable safety profile with only mild, non-serious AEs and no treatment discontinua-tions. Conclusions: Fibroin Syrup was safe and effective in reducing NERD-related symp-toms, supporting its role as a non-pharmacological therapeutic option in reflux disease management.