Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-01 @ 9:40 PM
Study NCT ID:
NCT05061732
Status:
RECRUITING
Last Update Posted:
2021-09-30
First Post:
2021-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helicobacter Pylori Eradication and Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064750', 'term': 'Rabeprazole'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D013752', 'term': 'Tetracycline'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4447}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2021-09-12', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence rate', 'timeFrame': '2 weeks during therapy', 'description': 'The proportion of subjects with good adherence. Good adherence was defined as that subjects took more than 80% of the total medication.'}, {'measure': 'Frequency of adverse events', 'timeFrame': '2 weeks during therapy', 'description': 'Any possible adverse events during the 14-day treatment period were recorded.'}], 'primaryOutcomes': [{'measure': 'Eradication rate of Helicobacter pylori', 'timeFrame': '6 weeks', 'description': 'Eradication of Helicobacter pylori was defined as negative result of urea breath test (\\<4‰ cut-off value).'}], 'secondaryOutcomes': [{'measure': 'Eradication rate of Helicobacter pylori resistant strains', 'timeFrame': '6 weeks', 'description': 'Eradication of Helicobacter pylori was defined as negative result of urea breath test (\\<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.'}, {'measure': 'Eradication rate of Helicobacter pylori susceptible strains', 'timeFrame': '6 weeks', 'description': 'Eradication of Helicobacter pylori was defined as negative result of urea breath test (\\<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).\n* 18-75 years old on the day of signing the ICF.\n* Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.\n\nExclusion Criteria:\n\n* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.\n* Subjects or guardians refused to participate in the trial.\n* Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.\n* Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.\n* Pregnant or lactating women.\n* Active peptic ulcer.\n* allergic to drugs used in the trial.\n* any other circumstances that are not suitable for recruitment."}, 'identificationModule': {'nctId': 'NCT05061732', 'briefTitle': 'Helicobacter Pylori Eradication and Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Helicobacter Pylori Eradication and Follow-up in Zhongshan Hospital', 'orgStudyIdInfo': {'id': 'B2021-376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RBCL', 'description': 'Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Bismuth potassium citrate', 'Drug: Clarithromycin', 'Drug: Levofloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'RBLM', 'description': 'Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Bismuth potassium citrate', 'Drug: Metronidazole', 'Drug: Levofloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'RBCM', 'description': 'Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Bismuth potassium citrate', 'Drug: Metronidazole', 'Drug: Clarithromycin']}, {'type': 'EXPERIMENTAL', 'label': 'RA', 'description': 'Rabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Amoxicillin']}, {'type': 'EXPERIMENTAL', 'label': 'RAB', 'description': 'Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Bismuth potassium citrate', 'Drug: Amoxicillin']}, {'type': 'EXPERIMENTAL', 'label': 'RAM', 'description': 'Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Metronidazole', 'Drug: Amoxicillin']}, {'type': 'EXPERIMENTAL', 'label': 'RBAM', 'description': 'Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Bismuth potassium citrate', 'Drug: Metronidazole', 'Drug: Amoxicillin']}, {'type': 'EXPERIMENTAL', 'label': 'RBAM4', 'description': 'Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Bismuth potassium citrate', 'Drug: Amoxicillin', 'Drug: Metronidazole']}, {'type': 'EXPERIMENTAL', 'label': 'RBDM', 'description': 'Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Bismuth potassium citrate', 'Drug: Metronidazole', 'Drug: Doxycycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RBTM', 'description': 'Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Bismuth potassium citrate', 'Drug: Metronidazole', 'Drug: Tetracycline']}], 'interventions': [{'name': 'Rabeprazole', 'type': 'DRUG', 'description': '20mg bid', 'armGroupLabels': ['RA', 'RAB', 'RAM', 'RBAM', 'RBAM4', 'RBCL', 'RBCM', 'RBDM', 'RBLM', 'RBTM']}, {'name': 'Bismuth potassium citrate', 'type': 'DRUG', 'description': '0.6g bid', 'armGroupLabels': ['RAB', 'RBAM', 'RBAM4', 'RBCL', 'RBCM', 'RBDM', 'RBLM', 'RBTM']}, {'name': 'Metronidazole', 'type': 'DRUG', 'description': '0.4g qid', 'armGroupLabels': ['RAM', 'RBAM', 'RBCM', 'RBLM']}, {'name': 'Clarithromycin', 'type': 'DRUG', 'description': '0.5g bid', 'armGroupLabels': ['RBCL', 'RBCM']}, {'name': 'Levofloxacin', 'type': 'DRUG', 'description': '0.5g qd', 'armGroupLabels': ['RBCL', 'RBLM']}, {'name': 'Amoxicillin', 'type': 'DRUG', 'description': '1g tid', 'armGroupLabels': ['RA', 'RAB', 'RAM', 'RBAM', 'RBAM4']}, {'name': 'Metronidazole', 'type': 'DRUG', 'description': '0.4g tid', 'armGroupLabels': ['RBAM4', 'RBDM', 'RBTM']}, {'name': 'Doxycycline', 'type': 'DRUG', 'description': '0.1g bid', 'armGroupLabels': ['RBDM']}, {'name': 'Tetracycline', 'type': 'DRUG', 'description': '0.5g qid', 'armGroupLabels': ['RBTM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Chen, MD', 'role': 'CONTACT', 'email': 'chenqimd@163.com', 'phone': '86-18817821405'}, {'name': 'Taotao Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Qi Chen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ying Fang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hao Wu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ruyuan Deng, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qi Chen, MD', 'role': 'CONTACT', 'email': 'chenqimd@163.com', 'phone': '86-17811921405'}], 'overallOfficials': [{'name': 'Taotao Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicaltrials.gov/', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 6 months and ending 5 years after the trial results were published.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available from the principal investigator Taotao Liu at liu.taotao@zs-hospital.sh.cn, beginning 6 months and ending 5 years after the trial results were published. The study protocol and statistical analysis plan are available online from https://clinicaltrials.gov/. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.', 'accessCriteria': 'All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}