A Pre-market, Two-stages Interventional Clinical Investigation to Evaluate the Safety and the Per… (NCT07563790) | Clinical Trial Compass
CompletedNot Applicable
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
Italy47 participantsStarted 2024-07-24
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.
Timeframe: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)