Evaluation of the Efficacy and Safety of Eolo in Patients With NERD
Status:
COMPLETED
Trial end date:
2025-05-30
Target enrollment:
Participant gender:
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).