Non-Erosive Gastroesophageal Reflux Disease (NERD)
Conditions
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.
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.
Interventions
Esomeprazole 20 mg administered orally once daily for 4 weeks.
DIETARY_SUPPLEMENTMirgeal® 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.
Sponsors
Liaquat University of Medical & Health Sciences
University of Urbino "Carlo Bo"
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastroesophageal Reflux Symptom Intensity Assessed by 0-10 Visual Analog Scale | Baseline, Week 2, and Week 4 | 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. |
| Change in Reflux Symptoms Assessed by the Reflux Symptom Index (RSI) | Baseline, Week 2, and Week 4 | 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. |
| Participant-Rated Palatability of Mirgeal® Gel Using the Study Palatability Questionnaire | Week 4 | 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. |
| Incidence of Adverse Events | From baseline through Week 4 | 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. |
| Percentage Treatment Adherence Assessed on a 0-100% Scale | Week 4 | 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. |
| Investigator Global Assessment of Performance (IGAP) Rating of Treatment Effectiveness | Week 4 | 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. |
Countries
Italy
Contacts
CONTACTProf. Davide Sisti, PhD
Outcome results
None listed