Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-29 @ 8:35 PM
Study NCT ID:
NCT05002595
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Biospecimen would be obtained for urease test (commercial name: CLOtest) or molecular test (DPO-PCR).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-22', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H. pylori infection status', 'timeFrame': '6 weeks', 'description': 'Rate of successful H. pylori eradication'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['H. Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '34883037', 'type': 'DERIVED', 'citation': 'Cho JH, Jin SY, Park S. Comparison of tailored Helicobacter pylori eradication versus modified bismuth quadruple therapy in Korea: a randomized controlled trial. Expert Rev Anti Infect Ther. 2022 Jun;20(6):923-929. doi: 10.1080/14787210.2022.2017280. Epub 2021 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment.\n\nDual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.', 'detailedDescription': 'The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'H. pylori-infected patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gastroscopy can be performed\n* H. pylori test and pathological analysis can be performed\n\nExclusion Criteria:\n\n* Age \\< 20 or \\> 80 years\n* Anemia (serum hemoglobin level \\< 10 g/dL)\n* Severe systemic disease\n* Advanced chronic liver disease\n* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics\n* History of H. pylori eradication\n* History of gastric surgery\n* Recent history of upper gastrointestinal bleeding'}, 'identificationModule': {'nctId': 'NCT05002595', 'briefTitle': 'H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Soonchunhyang University Hospital'}, 'officialTitle': 'Comparison of Helicobacter Pylori Treatment Between Modified Quadruple Therapy and Tailored Eradication Based on the Presence of Clarithromycin Resistance', 'orgStudyIdInfo': {'id': 'SCH-HP-2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Modified quadruple therapy', 'description': 'pantoprazole 40mg bid, amoxicillin 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 14 days', 'interventionNames': ['Drug: H. pylori eradication']}, {'label': 'Tailored eradication', 'description': 'pantoprazole 40mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid or pantoprazole 40mg bid, tetracycline 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 7 days', 'interventionNames': ['Drug: H. pylori eradication']}], 'interventions': [{'name': 'H. pylori eradication', 'type': 'DRUG', 'description': 'Antimicrobial agents for H. pylori eradication', 'armGroupLabels': ['Modified quadruple therapy', 'Tailored eradication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04401', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Digestive Disease Center, Soonchunhyang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jun-Hyung Cho, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jun-Hyung Cho', 'investigatorAffiliation': 'Soonchunhyang University Hospital'}}}}