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

To evaluate the performance of the "FIBROIN SYRUP" in reducing the gastroesophageal symptomatology in NERD patients.

The performance of the "FIBROIN SYRUP" in reducing the gastroesophageal symptomatology in NERD patients, will be evaluated by Reflux disease questionnaire (RDQ). The difference in the RDQ score will be evaluated between baseline and EOS visit will be was used to determine how many patients will be included for the STAGE 2. The RDQ score is a patient-reported measure used to assess the frequency and severity of GERD symptoms, such as heartburn and acid regurgitation. Each item is scored on a graded scale, and the responses are summed to produce a total score. The minimum RDQ score is 0, indicating no reflux-related symptoms, while the maximum score typically ranges up to 40 or 60, representing the most frequent and severe symptoms possible. Higher RDQ scores reflect greater symptom burden and disease severity, whereas lower scores indicate mild or absent symptoms.

Time frame: V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)

To evaluate the patient's satisfaction

To evaluate patient's satisfaction with FIBROIN SYRUP, a 5-Likert Scale will be used. Here's a breakdown of a typical 5 point Likert scale: Strongly Disagree (point 1) - Disagree (point 2) -Neutral (or Neither Agree nor Disagree) (point 3)- Agree (point 4) - Strongly Agree (point 5). This scale allows respondents to express the intensity of their feelings towards a given statement, making it easier to quantify subjective data. It's widely used because it's simple to understand and analyze.

Time frame: V2 (12 weeks form V0)

The Safety and the tolerability will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration.

The event, date of onset, severity, duration, and relationship to the device will be recorded. Subjects will receive a diary to record any deviation from the normal health status as well as any concomitant medication taken.

Time frame: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)

To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.

Safety and the tolerability will be monitored through Heart Rate measurement. Heart rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute (beats per minute, or bpm)

Time frame: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)

To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.

Safety and the tolerability will be monitored through measurement of the oxygen levels. 2 refers to the percentage of oxygen-saturated hemoglobin relative to total hemoglobin in the blood. The measurement of O2 is performed using a non-invasive device known as a pulse oximeter.

Time frame: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)