Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-25 @ 7:20 PM
Study NCT ID:
NCT01922505
Status:
COMPLETED
Last Update Posted:
2013-08-14
First Post:
2013-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eradication Rates of Helicobacter Pylori and Its Affecting Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016481', 'term': 'Helicobacter Infections'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-11', 'studyFirstSubmitDate': '2013-08-11', 'studyFirstSubmitQcDate': '2013-08-11', 'lastUpdatePostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication Rates of First-line Triple Therapy for Helicobacter pylori', 'timeFrame': 'Four weeks after completing eradication therapy', 'description': 'Non invasive H. pylori test (13C-urea breath test(UBT)) or invasive H. pylori test (Giemsa histology, Rapid Urease test) were performed after four weeks after completing eradication therapy.'}], 'secondaryOutcomes': [{'measure': 'Clinical Factors that Affect the Eradication', 'timeFrame': 'Four weeks after completing eradication therapy', 'description': 'Main variables are Cytochrome P450 2C19 (CYP2C19) genotype and Antibiotics resistance by H. pylori culture MICs result.\n\nOther variables are age, gender, underlying disease (hypertension, diabetes, chronic liver, lung, kidney diseases), cigarette smoking and alcohol use.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Helicobacter Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the trend of eradication rates of first-line triple therapy for Helicobacter pylori in recent ten years and clinical factors that affect the eradication in Korean.', 'detailedDescription': 'A PPI triple regimen combining a proton pump inhibitor(PPI) with two antibiotics (amoxicillin and clarithromycin) is currently considered the gold standard therapy for eradication of H. pylori. However, recently the eradication rate with first-line treatment has a tendency to decrease because of increasing antibiotics resistance. In addition, PPI is mainly metabolized by cytochrome p450 2C19 (CYP2C19) in the liver and several reports have suggested that differences in th CYP2C19 genotype are associated with H. pylori eradication failure. Thus, the first aim of this study is to investigate the trend of eradication rates of first-line triple therapy in recent ten years. And the second aim is to analyze the antibiotics resistance rate for H. pylori by using culture minimal inhibitory concentrations(MICs) result and to analyze the association between CYP2C19 genotype and eradication rate of H.pylori. And also investigate the other clinical factors (age, gender, underlying disease, cigarette smoking and alcohol use) that affect the eradication rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '92 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'H. pylori positive patient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who proven H. pylori infection by invasive or non-invasive H. pylori test\n* Patients treated with First-line triple therapy (PPI + Amoxicillin + Clarithromycin)\n\nExclusion Criteria:\n\n* Previous eradication therapy for H. pylori\n* Follow-up loss patients after eradication therapy\n* Other treatment regimen\n* Poor medication compliance (\\<80%)'}, 'identificationModule': {'nctId': 'NCT01922505', 'briefTitle': 'Eradication Rates of Helicobacter Pylori and Its Affecting Factors', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'The Trend of Eradication Rates of First-line Triple Therapy for Helicobacter Pylori and Clinical Factors That Affect the Eradication in Korean: Single Center Experience for Recent Ten Years', 'orgStudyIdInfo': {'id': 'B-1308-214-108'}, 'secondaryIdInfos': [{'id': '2012R1A1A3A04002680', 'type': 'OTHER', 'domain': 'National Research Foundation of Korea'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PPI triple therapy', 'description': '7-day PPI triple therapy regimen: PPI (esomeprazole 40 mg or omeprazole 20 mg or lansoprazole 30 mg or pantoprazole 40 mg or rabeprazole 20 mg) plus amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 7 days.', 'interventionNames': ['Drug: PPI triple therapy']}], 'interventions': [{'name': 'PPI triple therapy', 'type': 'DRUG', 'armGroupLabels': ['PPI triple therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Bundang-gu, Seongnam', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, M.D.', 'investigatorFullName': 'Nayoung Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}