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

NCT07041060 | Completed DMC

• 1 other identifier: DIMEC, University of Bologna
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-erosive Reflux Disease; Reflux Disease, Gastro-Esophageal; Nutraceutical

Keywords

non erosive reflux Disease; nutraceutical treatment

Outcome Measures

Primary Outcomes (1)

• Symptom relief and quality of life (QoL)

  GERD-HRQOL

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

Secondary Outcomes (1)

• RSI (Reflux Symptom Index)

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

Study Arms (3)

Group C

ACTIVE COMPARATOR

half-dose PPIs for 24 weeks

Dietary Supplement: EOLO; Dietary Supplement: Group C: Eolo

Group B

EXPERIMENTAL

Patients receiving half-dose PPIs alone for 12 weeks, then Eolo alone for 12 additional weeks.

Drug: PPI (proton pump inhibitor); Dietary Supplement: Group C: Eolo

Group A

EXPERIMENTAL

Patients receiving Eolo 24 we

Drug: PPI (proton pump inhibitor)

Interventions

EOLO DIETARY_SUPPLEMENT

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

Group C

PPI (proton pump inhibitor) DRUG

Received a half-dose of PPIs for 24 weeks

Group A; Group B

Group C: Eolo DIETARY_SUPPLEMENT

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

Group B; Group C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

DIMEC

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Non-Erosive Reflux Disease; Gastroesophageal Reflux

Interventions

Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Carlo Calabrese, Prof of Gastroenterology, PI

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 27, 2025
• Study Start: May 30, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (1)