Esomeprazole 20mg: Esomeprazole 20 mg administered orally once daily for 4 weeks.
Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.): Mirgeal Gel administered orally at a dose of 2 sticks daily (1 stick after lunch and 1 stick after dinner) for 4 weeks.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Written informed consent for study participation obtained prior to the start of the study.
Exclusion Criteria:
* 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.
* Use of proton pump inhibitors (PPIs), H2-antagonists, or systemic glucocorticoids within 2 weeks prior to enrollment.
* Pregnancy.
* Breastfeeding.
* Alcohol or drug abuse.
* Hypersensitivity to any of the study product components.
* Participation in another clinical trial within 30 days prior to enrollment.
* Lack of acceptance of written informed consent.
Primary outcome measure(s)
Change in GERD-Related Quality of Life Assessed by GERD-HRQL — Baseline, Week 2, and Week 4 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.
Trial sites (2)
Facility
City
Region
Status
Casa di Cura Quisisana
Rome
Lazio
Centro per la Gastroenterologia
Mercato San Severino
Salerno
More Liaquat University of Medical & Health Sciences trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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