Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 9:18 AM
Study NCT ID:
NCT07041060
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of Eolo in Patients With NERD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096663', 'term': 'Non-Erosive Reflux Disease'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054328', 'term': 'Proton Pump Inhibitors'}], 'ancestors': [{'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A: Patients receiving Eolo + half-dose PPIs for 12 weeks, then Eolo alone for 12 additional weeks.\n\nGroup B: Patients receiving half-dose PPIs alone for 12 weeks, then Eolo alone for 12 additional weeks.\n\nGroup C: Patients receiving half-dose PPIs only for 24 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-06-24', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom relief and quality of life (QoL)', 'timeFrame': 'Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-50; higher scores indicate worse quality of life.', 'description': 'GERD-HRQOL'}], 'secondaryOutcomes': [{'measure': 'RSI (Reflux Symptom Index)', 'timeFrame': 'Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-45; higher scores indicate worse symptoms.', 'description': 'Reflux Symptom Index'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non erosive reflux Disease', 'nutraceutical treatment'], 'conditions': ['Non-erosive Reflux Disease', 'Reflux Disease, Gastro-Esophageal', 'Nutraceutical']}, 'descriptionModule': {'briefSummary': '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.\n\nObjective: 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.\n\nMethods: 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).', 'detailedDescription': 'This study evaluates the efficacy and safety of a nutraceutical in combination with PPIs or alone compared to PPIs therapy in patients with NERD.\n\nA 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:Participants were eligible for the study if they met the following criteria:\n\n* 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.\n* Were aged between 18 and 80 years.\n* 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).\n* 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).\n\nExclusion Criteria:Patients were excluded if they had any of the following conditions:\n\n* Erosive esophagitis or Barrett's esophagus.\n* Gastric or duodenal ulcer.\n* History of major gastric or gastrointestinal surgery.\n* Atopy or food intolerances.\n* Thyroid disease.\n* Diabetes or metabolic syndrome.\n* Pregnancy or breastfeeding"}, 'identificationModule': {'nctId': 'NCT07041060', 'briefTitle': 'Evaluation of the Efficacy and Safety of Eolo in Patients With NERD', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'DIMEC, University of Bologna'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'half-dose PPIs for 24 weeks', 'interventionNames': ['Dietary Supplement: EOLO', 'Dietary Supplement: Group C: Eolo']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Patients receiving half-dose PPIs alone for 12 weeks, then Eolo alone for 12 additional weeks.', 'interventionNames': ['Drug: PPI (proton pump inhibitor)', 'Dietary Supplement: Group C: Eolo']}, {'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Patients receiving Eolo 24 we', 'interventionNames': ['Drug: PPI (proton pump inhibitor)']}], 'interventions': [{'name': 'EOLO', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts', 'armGroupLabels': ['Group C']}, {'name': 'PPI (proton pump inhibitor)', 'type': 'DRUG', 'description': 'Received a half-dose of PPIs for 24 weeks', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Group C: Eolo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts for 24 weeks', 'armGroupLabels': ['Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'DIMEC', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Carlo Calabrese, Prof of Gastroenterology, PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bologna'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'IPD used in the results publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Carlo Calabrese', 'investigatorAffiliation': 'University of Bologna'}}}}