Gastroesophageal reflux disease (GERD) is a common condition that can cause symptoms including heartburn, acid regurgitation, sour taste and other upper gastrointestinal complaints. This prospective, multicenter, randomized, controlled, non-profit clinical trial will evaluate the clinical efficacy and safety of Mirgeal® Gel, a dietary supplement containing sodium alginate and standardized extracts of licorice (Glycyrrhiza glabra) and blueberry (Vaccinium myrtillus), when used as an add-on to esomeprazole in adults with non-erosive gastroesophageal reflux disease (NERD).
A total of 140 participants will be randomly assigned in a 1:1 ratio to receive either esomeprazole 20 mg/day plus Mirgeal® Gel, 2 sticks per day (1 after lunch and 1 after dinner), or esomeprazole 20 mg/day alone for 4 continuous weeks. Clinical assessments will be performed at baseline and after 2 and 4 weeks of treatment. The study will assess whether adding Mirgeal® Gel to standard proton pump inhibitor therapy improves reflux-related symptoms and quality of life compared with esomeprazole alone.
Adults aged ≥18 years.
Males and females.
Diagnosis of non-erosive gastroesophageal reflux disease (NERD), based on the absence of macroscopic lesions of the distal esophageal mucosa on endoscopy performed within 6 months prior to enrollment.
Heartburn and/or acid regurgitation at least 3 times per week during the 2 weeks prior to enrollment.
Active gastric or duodenal ulcer within the previous 3 months.
Previous surgery involving the esophagus or treated upper gastrointestinal tract.
Absence of erosive esophagitis or Barrett's esophagus.
Severe renal or hepatic impairment.
Parallel
Esomeprazole 20mg
DrugEsomeprazole 20 mg administered orally once daily for 4 weeks.
Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.)
Dietary supplementMirgeal Gel administered orally at a dose of 2 sticks daily (1 stick after lunch and 1 stick after dinner) for 4 weeks.
Change in GERD-Related Quality of Life Assessed by GERD-HRQL
Change in gastroesophageal reflux disease symptoms and their impact on quality of life will be assessed using the validated Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire. The questionnaire includes 10 items scored from 0 (no problem) to 5 (severe problem), with higher scores indicating greater symptom burden. GERD-HRQL will be administered at baseline, Week 2, and Week 4.
Change in Reflux Symptoms Assessed by the Reflux Symptom Index (RSI)
Change in reflux-related symptoms will be assessed using the Reflux Symptom Index (RSI). The RSI evaluates nine reflux-related symptoms, with each item scored from 0 (no problem) to 5 (severe problem). The total score ranges from 0 to 45, with higher scores indicating greater symptom severity.
Change in Gastroesophageal Reflux Symptom Intensity Assessed by 0-10 Visual Analog Scale
Change from baseline in the intensity of regurgitation, heartburn, and sour taste in the mouth, assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no symptoms and 10 indicates the worst possible symptom. Higher scores indicate greater symptom severity. Assessments will be performed at baseline, Week 2, and Week 4.
Investigator Global Assessment of Performance (IGAP) Rating of Treatment Effectiveness
At Week 4, the investigator will assess overall treatment effectiveness using the Investigator Global Assessment of Performance (IGAP), based on the participant's overall clinical evaluation, including patient-reported symptoms, completed questionnaires, and use of rescue medications. Treatment effectiveness will be rated from poor to excellent, with higher ratings indicating better treatment performance.
Participant-Rated Palatability of Mirgeal® Gel Using the Study Palatability Questionnaire
Participants assigned to Mirgeal® Gel will assess the palatability of the study product at Week 4 using the study palatability questionnaire. Participants will provide an overall rating ranging from bad to excellent, with higher ratings indicating better palatability.
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Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator
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