Mirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease

Effect of the Use of Alginate Combined With Licorice and Blueberry in the Symptomatic Treatment of Adult Patients With Gastroesophageal Reflux Disease

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.

This is a prospective, multicenter, randomized, controlled clinical trial designed to evaluate the safety and clinical efficacy of Mirgeal® Gel as an add-on to proton pump inhibitor therapy in adult patients with non-erosive gastroesophageal reflux disease (NERD). The study is designed to evaluate the superiority in clinical efficacy of the combination of esomeprazole plus Mirgeal® Gel compared with esomeprazole alone.

Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.) is a dietary supplement in stick form containing sodium alginate and standardized derivatives of Glycyrrhiza glabra and Vaccinium myrtillus. Participants will be randomly allocated in a 1:1 ratio to one of two treatment groups. The intervention group will receive esomeprazole 20 mg/day plus Mirgeal® Gel at a dose of 2 sticks per day, with 1 stick taken after lunch and 1 stick after dinner. The control group will receive esomeprazole 20 mg/day alone. Treatment will continue for 4 continuous weeks.

Treatment will begin following the baseline assessment. Clinical visits will be conducted at baseline and after 2 and 4 weeks of treatment. Participants will be monitored throughout the study for clinical outcomes, safety and treatment adherence. The total duration of participation for each subject will be 4 weeks, with no post-treatment follow-up period.

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.