NCT07041060

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

Evaluation of the Efficacy and Safety of a Nutraceutical Containing Sodium Alginate, Sodium Bicarbonate, PEA, a Blend of Opuntia Ficus Indica, and Olea Europaea, Musa Paradisiaca, and Ginger in Patients With NERD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EOLO	Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts
DRUG	PPI (proton pump inhibitor)	Received a half-dose of PPIs for 24 weeks
DIETARY_SUPPLEMENT	Group C: Eolo	Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts for 24 weeks

Timeline

• Start date: 2025-05-30
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

1 site across 1 country: Italy