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.

Study Overview

• Status: Completed
• Conditions: GERD (Heartburn, Regurgitation, and Dyspepsia); Gastroesophageal Reflux (GERD)
• Intervention / Treatment: Device: Syrup made by hyaluronic acid

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40121
      • UOC Medicina Interna Cardiovascolare - Centro Endoscopia Digestiva - Policlinico di Sant'Orsola - Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adult patients suffering from gastroesophageal reflux disease	Device: Syrup made by hyaluronic acid; Syrup made by hyaluronic acid that forms a protective layer that adheres to the esophageal mucosa and has a mechanical action

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Rose Pharma SA

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): August 8, 2025

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: GastroEsophageal Reflux GERD
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastroesophageal Reflux; Dyspepsia; Heartburn
• Other Study ID Numbers: RF-FibroinS-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No