Non-erosive Reflux DiseaseNCT07041060
Evaluation of the Efficacy and Safety of Eolo in Patients With NERD
A study testing EOLO, PPI (proton pump inhibitor) and Group C: Eolo in people with Non-erosive Reflux Disease and Reflux Disease, Gastro-Esophageal, run by University of Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-erosive Reflux Disease, Reflux Disease, Gastro-Esophageal, Nutraceutical
- What is being tested?
- EOLO, PPI (proton pump inhibitor) and Group C: Eolo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2025to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
Read the 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).
- Being tested
- EOLO, PPI (proton pump inhibitor), Group C: Eolo
- Keywords
- non erosive reflux Disease, nutraceutical treatment
- Medical subject headings
- Non-Erosive Reflux Disease, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOLODietary supplement
Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts
PPI (proton pump inhibitor)Drug
Received a half-dose of PPIs for 24 weeks
Group C: EoloDietary supplement
Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | half-dose PPIs for 24 weeks Receives: 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. Receives: Drug: PPI (proton pump inhibitor); Dietary Supplement: Group C: Eolo |
| Group A | Experimental | Patients receiving Eolo 24 we Receives: Drug: PPI (proton pump inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom relief and quality of life (QoL)
GERD-HRQOL
Measured: 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)
Reflux Symptom Index
Measured: Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-45; higher scores indicate worse symptoms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start30 May 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Calabrese, University of Bologna
- Investigators
- Carlo Calabrese, Prof of Gastroenterology, PI, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041060
- Sponsor's protocol ID
- DIMEC, University of Bologna
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07041060
- Acronym / sponsor ID
- DIMEC, University of Bologna
- Keywords
- non erosive reflux Disease, nutraceutical treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Dietary Supplement: EOLO, Dietary Supplement: Group C: Eolohalf-dose PPIs for 24 weeks |
| Group B | Experimental | Drug: PPI (proton pump inhibitor), Dietary Supplement: Group C: EoloPatients receiving half-dose PPIs alone for 12 weeks, then Eolo alone for 12 additional weeks. |
| Group A | Experimental | Drug: PPI (proton pump inhibitor)Patients receiving Eolo 24 we |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOLOEolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts | Dietary supplement | Group C |
| PPI (proton pump inhibitor)Received a half-dose of PPIs for 24 weeks | Drug | Group A, Group B |
| Group C: EoloEolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts for 24 weeks | Dietary supplement | Group B, Group C |
Primary outcome
Symptom relief and quality of life (QoL)
Time frame: Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-50; higher scores indicate worse quality of life.
GERD-HRQOL
1 secondary outcome
RSI (Reflux Symptom Index)
Time frame: Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-45; higher scores indicate worse symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Calabrese, Prof of Gastroenterology, PI principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOLO, PPI (proton pump inhibitor) and Group C: Eolo in people with Non-erosive Reflux Disease and Reflux Disease, Gastro-Esophageal, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom relief and quality of life (QoL) (time frame: Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-50; higher scores indicate worse quality of life.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.