A Pre-market, Two-stages Interventional Clinical Investigation to Evaluate the Safety and the Performance of Fibroin Syrup in Reducing the Gastroesophageal Reflux Disease (GERD) Symptomatology in Nonerosive Reflux Disease (NERD) Patients

A Pre-market, Two-stages Interventional Clinical Investigation to Evaluate the Safety and the Performance of Fibroin Syrup in Reducing the Gastroesophageal Reflux Disease (GERD) Symptomatology in Nonerosive Reflux Disease (NERD) Patients

This study involves a medical device in the form of syrup, not yet on the market and tested for the first time in humans, named "FIBROIN SYRUP". The intended use is to reduce the GastroEsophageal Reflux Disease (GERD) symptoms such as heartburn, epigastric pain, irritative and nocturnal cough, dysphagia and dysphonia, which may occur especially after meals or during the night due to lying position. "FIBROIN SYRUP" has never been tested on humans and this study aims to evaluate the safety, tolerability and efficacy of the medical device when taken after the main meals (breakfast, lunch, and dinner; total: 3 sticks/day) for 6 weeks.

This study requires 4 outpatient visits in 6 weeks and it is addressed to patients over 18 years old suffering from heartburn and/or regurgitation for at least 8 weeks

Inclusion Criteria

• Patient who signed Informed consent form;
• Male or Female over 18 years old at the time of the signature of the Informed consent form;
• Symptomatic non-erosive reflux disease (heartburn and/or regurgitation) for at least 8 weeks;
• RDQ (Reflux Disease Questionnaire) score ≥ 12 at baseline (questionnaire specific for reporting the frequency and severity of upper gastrointestinal symptoms);
• Willingness to follow all study procedures, including attending all site visits, tests and examinations.

Exclusion Criteria:

• Esophagitis according to the Los Angeles classification (grade A to D);
• Diagnosis of Helicobacter pylori infection;
• Use of proton pump inhibitors or H2 receptor antagonists in the previous 4 weeks;
• Uncontrolled cardiac, renal, liver or pulmonary disease;
• Diabetes;
• Active malignant neoplasia;
• Pregnancy or breast-feeding;
• Known allergy to device components;
• Simultaneous participation in an interventional study or participation in an interventional study in the last 1 month before study inclusion;
• Known drug and/or alcohol abuse;
• Mental incapacity that precludes adequate understanding or cooperation.