Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-06 @ 2:26 PM
Study NCT ID:
NCT04029493
Status:
UNKNOWN
Last Update Posted:
2019-07-23
First Post:
2019-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Situation of Re-infection of Helicobacter Pylori After Successful Eradication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084063', 'term': 'Reinfection'}], 'ancestors': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-21', 'studyFirstSubmitDate': '2019-07-21', 'studyFirstSubmitQcDate': '2019-07-21', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of re-infection', 'timeFrame': '4 years', 'description': 'The rate of re-infection will be described by the frequency and percentage.'}], 'secondaryOutcomes': [{'measure': 'The influence factors of the rate of re-infection', 'timeFrame': '4 years', 'description': 'The chi-square test will be used to compare the influence factors of the rate of re-infection.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Re-infection'], 'conditions': ['Helicobacter Pylori']}, 'descriptionModule': {'briefSummary': 'The patients who accept the quadruple eradication program of the helicobacter pylori and success to eradicate helicobacter pylori will be followed-up to observe the situation of re-infection of helicobacter pylori.', 'detailedDescription': 'The patients with helicobacter pylori accepted he quadruple eradication program of the helicobacter pylori.They will be followed-up from 1 year to 5 years to observe the situation of re-infection of helicobacter pylori.The rate of the re-infection will be described by frequency and percentage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients in Shandong province, aged between 18 and 70 years old, with previous positive H. pylori infection that suceessed to be eradicated by therapies are included.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.\n\nExclusion Criteria:\n\n* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.'}, 'identificationModule': {'nctId': 'NCT04029493', 'briefTitle': 'The Situation of Re-infection of Helicobacter Pylori After Successful Eradication', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'The Situation of Re-infection of Helicobacter Pylori After Successful Eradication', 'orgStudyIdInfo': {'id': '2018SDU-QILU-G116'}}, 'contactsLocationsModule': {'locations': [{'zip': '257000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiuli Zuo, MD,PhD', 'role': 'CONTACT', 'email': 'zuoxiuli@sina.com', 'phone': '15588818685', 'phoneExt': '15588818685'}, {'name': 'Tian Ma, MD', 'role': 'CONTACT', 'email': 'matian1002@163.com', 'phone': '18769781098', 'phoneExt': '15588818685'}, {'name': 'Junnan Hu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chen Qiao, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Xiuli Zuo, MD,PhD', 'role': 'CONTACT', 'email': 'zuoxiuli@sina.com', 'phone': '15588818685', 'phoneExt': '053188369277'}, {'name': 'Tian Ma, MD', 'role': 'CONTACT', 'email': 'matian1002@163.com', 'phone': '18769781098', 'phoneExt': '053188369277'}], 'overallOfficials': [{'name': 'Xiuli Zuo, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Qilu Hospital of Shandong University'}, {'name': 'Tian Ma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of Qilu Hospital gastroenterology department', 'investigatorFullName': 'Xiuli Zuo', 'investigatorAffiliation': 'Shandong University'}}}}