Non-erosive Reflux Disease, Nutraceutical, Reflux Disease, Gastro-Esophageal
Conditions
Keywords
non erosive reflux Disease, nutraceutical treatment
Brief summary
Background: Non-erosive reflux disease (NERD) is a prevalent subtype of gastroesophageal reflux disease (GERD), often inadequately managed with proton pump inhibitors (PPIs) alone. Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts, has been proposed as an adjunctive therapy to enhance symptom relief and mucosal protection. Objective: This study evaluates the efficacy and safety of a nutraceutical \[Eolo®, Cristalfarma s.r.l. - Milan (IT)\] in combination with PPIs or alone compared to PPIs therapy in patients with NERD. Methods: A single-center, randomized, parallel-group study was conducted, enrolling 60 patients with NERD. Participants were randomized into three groups: (A) Eolo + half-dose PPIs for 12 weeks, (B) half-dose PPIs alone for 12 weeks, and (C) a control group receiving only half-dose PPIs for 24 weeks. After 12 weeks, groups A and B discontinued PPIs and continued with Eolo alone for an additional 12 weeks. Symptom relief and quality of life (QoL) were assessed using GERD-HRQOL and RSI questionnaires at baseline (T0), 12 weeks (T1), and 24 weeks (T2).
Detailed description
This study evaluates the efficacy and safety of a nutraceutical in combination with PPIs or alone compared to PPIs therapy in patients with NERD. A single-center, randomized, parallel-group study was conducted, enrolling 60 patients with NERD. Participants were randomized into three groups: (A) Eolo + half-dose PPIs for 12 weeks, (B) half-dose PPIs alone for 12 weeks, and (C) a control group receiving only half-dose PPIs for 24 weeks. After 12 weeks, groups A and B discontinued PPIs and continued with Eolo alone for an additional 12 weeks. Symptom relief and quality of life (QoL) were assessed using GERD-HRQOL and RSI questionnaires at baseline (T0), 12 weeks (T1), and 24 weeks (T2).
Interventions
DIETARY_SUPPLEMENTEOLO
Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts
Received a half-dose of PPIs for 24 weeks
DIETARY_SUPPLEMENTGroup C: Eolo
Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts for 24 weeks
Sponsors
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Group A: Patients receiving Eolo + half-dose PPIs for 12 weeks, then Eolo alone for 12 additional weeks. Group B: Patients receiving half-dose PPIs alone for 12 weeks, then Eolo alone for 12 additional weeks. Group C: Patients receiving half-dose PPIs only for 24 weeks.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Participants were eligible for the study if they met the following criteria: * Had a diagnosis of non-erosive reflux disease (NERD) with typical reflux symptoms persisting for at least three months and occurring at least three times per week in the month preceding the study screening visit. * Were aged between 18 and 80 years. * Had been on therapy with a proton pump inhibitor (PPI) at a standard dosage for at least six weeks (40 mg pantoprazole/esomeprazole, 30 mg lansoprazole, or 20 mg omeprazole/rabeprazole). * Had a diagnosis of NERD confirmed by the absence of macroscopic lesions of the distal esophageal mucosa on endoscopy performed within six months before the screening visit and a positive score on a validated questionnaire (Reflux Disease Questionnaire, RDQ Score ≥ 8).
Exclusion criteria
Patients were excluded if they had any of the following conditions: * Erosive esophagitis or Barrett's esophagus. * Gastric or duodenal ulcer. * History of major gastric or gastrointestinal surgery. * Atopy or food intolerances. * Thyroid disease. * Diabetes or metabolic syndrome. * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom relief and quality of life (QoL) | Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-50; higher scores indicate worse quality of life. | GERD-HRQOL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RSI (Reflux Symptom Index) | Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-45; higher scores indicate worse symptoms. | Reflux Symptom Index |
Countries
Italy
Outcome results
None listed