CompletedNot Applicable

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

Italy60 participantsStarted 2025-05-30

Plain-language 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).

Who can participate

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ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Symptom relief and quality of life (QoL)

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

Trial details

NCT IDNCT07041060

SponsorUniversity of Bologna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-30

View on ClinicalTrials.gov More Non-erosive Reflux Disease trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.