GERD (Heartburn, Regurgitation, and Dyspepsia)NCT07563790
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 study testing Syrup made by hyaluronic acid in people with GERD (Heartburn, Regurgitation, and Dyspepsia) and Gastroesophageal Reflux (GERD), run by Rose Pharma SA at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD (Heartburn, Regurgitation, and Dyspepsia), Gastroesophageal Reflux (GERD)
- What is being tested?
- Syrup made by hyaluronic acid
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jul 2024to 8 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOC Medicina Interna Cardiovascolare - Centro Endoscopia Digestiva - Policlinico di Sant'Orsola - Bologna
Bologna, BO, 40121
About this study
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.
Read the detailed description
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
- Being tested
- Syrup made by hyaluronic acid
- Keywords
- GastroEsophageal Reflux GERD
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syrup made by hyaluronic acidDevice
Syrup made by hyaluronic acid that forms a protective layer that adheres to the esophageal mucosa and has a mechanical action
| Study group | Role | What they receive |
|---|---|---|
| Adult patients suffering from gastroesophageal reflux disease | Experimental | Not described Receives: Device: Syrup made by hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start24 Jul 2024
- Primary completion31 Jul 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD (Heartburn, Regurgitation, and Dyspepsia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Medical device under form of syrup with a mechanical action
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rose Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563790
- Sponsor's protocol ID
- RF-FibroinS-2024
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07563790
- Acronym / sponsor ID
- RF-FibroinS-2024
- Keywords
- GastroEsophageal Reflux GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Rose Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Medical device under form of syrup with a mechanical action
| Arm | Type | Receives |
|---|---|---|
| Adult patients suffering from gastroesophageal reflux disease | Experimental | Device: Syrup made by hyaluronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syrup made by hyaluronic acidSyrup made by hyaluronic acid that forms a protective layer that adheres to the esophageal mucosa and has a mechanical action | Device | Adult patients suffering from gastroesophageal reflux disease |
Primary outcome
To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.
Time frame: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
Safety will be monitored through Blood pressure measurement. Blood pressure readings are typically expressed in millimeters of mercury (mmHg)
5 secondary outcomes
To evaluate the performance of the "FIBROIN SYRUP" in reducing the gastroesophageal symptomatology in NERD patients.
Time frame: V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
To evaluate the patient's satisfaction
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.
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.
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.
Time frame: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syrup made by hyaluronic acid in people with GERD (Heartburn, Regurgitation, and Dyspepsia) and Gastroesophageal Reflux (GERD), run by Rose Pharma SA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs. (time frame: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.