Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:02 AM
Study NCT ID:
NCT06457334
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Helicobacter Pylori Eradication on Gastroesophageal RefIux Disease (GERD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-09', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-06-09', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication of Helicobacter pylori after triple therapy', 'timeFrame': '1\\2024 to 12\\2024', 'description': 'H.pylori eradication will be assessed using the endoscope'}, {'measure': 'Effect of Helicobacter pylori eradication on Gastroesophageal RefIux disease (GERD) syptomes', 'timeFrame': '1\\2024 to 12\\2024', 'description': 'Evaluate the effect of H.pylori eradication on Gastroesophageal-reflux disease and correlate with GERD symptoms improvement.'}]}, 'conditionsModule': {'keywords': ['Helicobacter pylori'], 'conditions': ['GERD']}, 'referencesModule': {'references': [{'pmid': '18402185', 'type': 'BACKGROUND', 'citation': 'Ceylan A, Kirimi E, Tuncer O, Turkdogan K, Ariyuca S, Ceylan N. Prevalence of Helicobacter pylori in children and their family members in a district in Turkey. J Health Popul Nutr. 2007 Dec;25(4):422-7.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the effect of H.pylori eradication on Gastroesophageal-reflux disease and symptoms improvement', 'detailedDescription': 'HeIicobacter PyIori (H.pyIori) is a gram-negative spiral shaped bacterium that affects up to 50% of the population worldwide, with a higher prevalences in the developing countries,Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus, resulting in a significant economic burden in direct and indirect costs and adversely affects the quality of life.GERD is caused by multiple different mechanisms that can be intrinsic, structural, or both, leading to the disruption of the esophago-gastric junction barrier resulting in exposure of the esophagus to acidic gastric contents, Clinically, GERD typically manifests with symptoms of heartburn and regurgitation. It can also present in an atypical fashion with extra-esophageal symptoms such as chest pain, dental erosions, chronic cough, laryngitis, or asthma.The relationship between H. pylori and gastroesophageal reflux disease (GERD) is still unclear, and the effect of H. pylori eradication on GERD treatment is unknown.Several studies have shown the inverse relationship between the occurrence of GERD and H.pyIori infection, in particular an increased severity of the disease is documented in patients with pre-existing symptoms .It has been showed that a markedly resolution of dyspepsia in patients at whom the eradication therapy was successful when compared with subjects with a persistent infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed as GERD clinically and endscopically.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients diagnosed as GERD clinically and endscopically.\n\nExclusion Criteria:\n\n* NO exclusion criteria'}, 'identificationModule': {'nctId': 'NCT06457334', 'briefTitle': 'Effect of Helicobacter Pylori Eradication on Gastroesophageal RefIux Disease (GERD)', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Helicobacter Pylori Eradication on Gastroesophageal RefIux Disease (GERD)', 'orgStudyIdInfo': {'id': 'H.pylori eradication on GERD'}}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Alrajhi Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Sara F Abdelhamid elgamal, master', 'role': 'CONTACT', 'email': 'sarafergany139@gmail.com', 'phone': '+201023524835'}, {'name': 'Rasha M Omar, lecturer', 'role': 'CONTACT', 'email': 'rasha.maree77@gmail.com', 'phone': '+201062821017'}], 'overallOfficials': [{'name': 'Saad Z Mahmoud, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Sara Fergany Abdelhamid Elgamal', 'investigatorAffiliation': 'Assiut University'}}}}