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

University of Bologna

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07041060

DIMEC, University of Bologna

Details and patient eligibility

About

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).

Full 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).

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Group C

Active Comparator group

Description:

half-dose PPIs for 24 weeks

Treatment:

Dietary Supplement: EOLO

Dietary Supplement: Group C: Eolo

Group B

Experimental group

Description:

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

Treatment:

Drug: PPI (proton pump inhibitor)

Dietary Supplement: Group C: Eolo

Group A

Experimental group

Description:

Patients receiving Eolo 24 we

Treatment:

Drug: PPI (proton pump inhibitor)