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

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.