Non-Erosive Gastroesophageal Reflux Disease (NERD)NCT07790549
Mirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease
A study testing Esomeprazole 20mg and Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.) in people with Non-Erosive Gastroesophageal Reflux Disease (NERD), run by Liaquat University of Medical & Health Sciences at 2 sites in Italy.
Trial summary
Gastroesophageal reflux disease (GERD) is a common condition that can cause symptoms including heartburn, acid regurgitation, sour taste and other upper gastrointestinal complaints. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Erosive Gastroesophageal Reflux Disease (NERD)
- What is being tested?
- Esomeprazole 20mg and Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesItaly
- Study dates
- 7 Sep 2026to 29 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
Centro per la Gastroenterologia
Mercato San Severino, Salerno, 84085
Orazio Labianca, MD, Orazio-labianca@libero.it
Casa di Cura Quisisana
Rome, Lazio, 00197
Chiara Pasquale, MD, chiara.pasquale@virgilio.it
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Esomeprazole 20mg, Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 20mgDrug
Esomeprazole 20 mg administered orally once daily for 4 weeks.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Esomeprazole 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 2, and Week 4
Secondary outcomes (6)
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.
Measured: Baseline, Week 2, and Week 4
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.
Measured: 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.
Measured: Week 4
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.
Measured: Week 4
Incidence of Adverse Events
Safety and tolerability will be assessed by recording adverse events reported by participants during the study. Adverse events will be documented throughout the treatment period.
Measured: From baseline through Week 4
Percentage Treatment Adherence Assessed on a 0-100% Scale
Treatment adherence will be assessed at Week 4 and reported as a percentage from 0% to 100%, with higher percentages indicating greater adherence to the assigned treatment regimen. Adherence will also be assessed through return of unused Mirgeal® Gel packs or sticks, as applicable.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start7 Sep 2026 (estimated)
- Primary completion29 Jan 2027 (estimated)
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Erosive Gastroesophageal Reflux Disease (NERD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790549
- Sponsor's protocol ID
- 177_9giugno2026_MIRGEAL_Sisti
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Alginate Combined With Licorice and Blueberry in the Symptomatic Treatment of Adult Patients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT07790549
- Acronym / sponsor ID
- 177_9giugno2026_MIRGEAL_Sisti
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole Plus Mirgeal® Gel | Experimental | Drug: Esomeprazole 20mg, Dietary Supplement: Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.)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. |
| Esomeprazole Alone | Active comparator | Drug: Esomeprazole 20mgParticipants will receive esomeprazole 20 mg/day alone for 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole 20mgEsomeprazole 20 mg administered orally once daily for 4 weeks. | Drug | Esomeprazole Alone, Esomeprazole Plus Mirgeal® Gel |
| 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. | Dietary supplement | Esomeprazole Plus Mirgeal® Gel |
Primary outcome
Change in GERD-Related Quality of Life Assessed by GERD-HRQL
Time frame: 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.
6 secondary outcomes
Change in Reflux Symptoms Assessed by the Reflux Symptom Index (RSI)
Time frame: Baseline, Week 2, and Week 4
Change in Gastroesophageal Reflux Symptom Intensity Assessed by 0-10 Visual Analog Scale
Time frame: Baseline, Week 2, and Week 4
Investigator Global Assessment of Performance (IGAP) Rating of Treatment Effectiveness
Time frame: Week 4
Participant-Rated Palatability of Mirgeal® Gel Using the Study Palatability Questionnaire
Time frame: Week 4
Incidence of Adverse Events
Time frame: From baseline through Week 4
Percentage Treatment Adherence Assessed on a 0-100% Scale
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esomeprazole 20mg and Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.) in people with Non-Erosive Gastroesophageal Reflux Disease (NERD), run by Liaquat University of Medical & Health Sciences at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Davide Sisti, PhD (+39 0722 303301., davide.sisti@uniurb.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GERD-Related Quality of Life Assessed by GERD-HRQL (time frame: Baseline, Week 2, and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.