Evaluation of the Efficacy and Safety of Eolo in Patients With NERD

University of Bologna60 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Interventions

EOLODIETARY_SUPPLEMENT

Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts

PPI (proton pump inhibitor)DRUG

Received a half-dose of PPIs for 24 weeks

Group C: EoloDIETARY_SUPPLEMENT

Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts for 24 weeks

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Symptom relief and quality of life (QoL)

GERD-HRQOL

Time frame: Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-50; higher scores indicate worse quality of life.

Secondary Outcomes

RSI (Reflux Symptom Index)

Reflux Symptom Index

Time frame: Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-45; higher scores indicate worse symptoms.