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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients suffering from gastroesophageal reflux disease | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Syrup made by hyaluronic acid | Device | Syrup made by hyaluronic acid that forms a protective layer that adheres to the esophageal mucosa and has a mechanical action |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs. | Safety will be monitored through Blood pressure measurement. Blood pressure readings are typically expressed in millimeters of mercury (mmHg) | V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC Medicina Interna Cardiovascolare - Centro Endoscopia Digestiva - Policlinico di Sant'Orsola - Bologna | Bologna | BO | 40121 | Italy |
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Medical device under form of syrup with a mechanical action
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| 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. | 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. | 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) | 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. | V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0) |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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