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

NCT07790549 | Not Yet Recruiting DMC

• 1 other identifier: 177_9giugno2026_MIRGEAL_Sisti
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Non-Erosive Gastroesophageal Reflux Disease (NERD)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 2, and Week 4

Secondary Outcomes (6)

• Change in Reflux Symptoms Assessed by the Reflux Symptom Index (RSI)

  Baseline, Week 2, and Week 4

• Change in Gastroesophageal Reflux Symptom Intensity Assessed by 0-10 Visual Analog Scale

  Baseline, Week 2, and Week 4

• Investigator Global Assessment of Performance (IGAP) Rating of Treatment Effectiveness

  Week 4

• Participant-Rated Palatability of Mirgeal® Gel Using the Study Palatability Questionnaire

  Week 4

• Incidence of Adverse Events

  From baseline through Week 4

Study Arms (2)

Esomeprazole Plus Mirgeal® Gel

EXPERIMENTAL

Participants will receive esomeprazole 20 mg/day plus Mirgeal® Gel, 2 sticks daily (1 stick after lunch and 1 stick after dinner), for 4 weeks.

Drug: Esomeprazole 20mg; Dietary Supplement: Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.)

Esomeprazole Alone

ACTIVE COMPARATOR

Participants will receive esomeprazole 20 mg/day alone for 4 weeks.

Drug: Esomeprazole 20mg

Interventions

Esomeprazole 20mg DRUG

Esomeprazole 20 mg administered orally once daily for 4 weeks.

Esomeprazole Alone; Esomeprazole Plus Mirgeal® Gel

Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.) DIETARY_SUPPLEMENT

Mirgeal Gel administered orally at a dose of 2 sticks daily (1 stick after lunch and 1 stick after dinner) for 4 weeks.

Esomeprazole Plus Mirgeal® Gel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• University of Urbino "Carlo Bo": collaborator

Study Sites (2)

Casa di Cura Quisisana

Rome, Lazio, 00197, Italy

Location

Centro per la Gastroenterologia

Mercato San Severino, Salerno, 84085, Italy

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Prof. Davide Sisti, PhD

CONTACT

+39 0722 303301.; davide.sisti@uniurb.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 7, 2026
• Primary Completion (Estimated): January 29, 2027
• Study Completion (Estimated): January 29, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

IT (2)