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Completed

NCT Number: 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

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.

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Key information

Conditions

GERD (Heartburn, Regurgitation, and Dyspepsia) Deglutition Disorders Digestive System Diseases Dyspepsia Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastroesophageal Reflux (GERD) Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UOC Medicina Interna Cardiovascolare - Centro Endoscopia Digestiva - Policlinico di Sant'Orsola - Bologna

Bologna, BO, 40121, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

    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.

  2. To evaluate the patient's satisfaction

    Time frame: V2 (12 weeks form V0)

    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.

  3. 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)

    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.

  4. 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 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)

  5. 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 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.

Sponsors and collaborators

Lead sponsor

Rose Pharma SA

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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