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

NCT ID: NCT07041060

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2025-05-30

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group C

half-dose PPIs for 24 weeks

Group Type: ACTIVE_COMPARATOR

EOLO

Intervention Type: DIETARY_SUPPLEMENT

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

Group C: Eolo

Intervention Type: DIETARY_SUPPLEMENT

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

Group B

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

Group Type: EXPERIMENTAL

PPI (proton pump inhibitor)

Intervention Type: DRUG

Received a half-dose of PPIs for 24 weeks

Group C: Eolo

Intervention Type: DIETARY_SUPPLEMENT

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

Group A

Patients receiving Eolo 24 we

Group Type: EXPERIMENTAL

PPI (proton pump inhibitor)

Intervention Type: DRUG

Received a half-dose of PPIs for 24 weeks

Interventions

EOLO

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

Intervention Type: DIETARY_SUPPLEMENT

PPI (proton pump inhibitor)

Received a half-dose of PPIs for 24 weeks

Intervention Type: DRUG

Group C: Eolo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion 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

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Carlo Calabrese

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Calabrese, Prof of Gastroenterology, PI

Role: PRINCIPAL_INVESTIGATOR

University of Bologna

Locations

DIMEC

Bologna, , Italy

Countries

Italy

Other Identifiers

DIMEC, University of Bologna

Identifier Type: -

Identifier Source: org_study_id