Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-02 @ 5:51 PM
Study NCT ID:
NCT02674802
Status:
UNKNOWN
Last Update Posted:
2016-02-04
First Post:
2016-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reinfection After Eradication of Helicobacter Pylori Infection
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', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helicobacter Pylori Infection', 'timeFrame': 'six months', 'description': 'Retrospective study'}, {'measure': 'Helicobacter Pylori Infection', 'timeFrame': 'After regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months', 'description': 'Prospective study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Reinfection', 'Eradication therapy', 'C-urea breath test', 'Helicobacter Pylori'], 'conditions': ['Bacterial Infection Due to Helicobacter Pylori (H. Pylori)', 'Eradication Therapy of Helicobacter Pylori', 'Detection of Helicobacter Pylori']}, 'referencesModule': {'references': [{'pmid': '22491499', 'type': 'BACKGROUND', 'citation': "Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084."}, {'pmid': '20302589', 'type': 'BACKGROUND', 'citation': 'Silva FM, Navarro-Rodriguez T, Barbuti RC, Mattar R, Hashimoto CL, Eisig JN. Helicobacter pylori reinfection in Brazilian patients with peptic ulcer disease: a 5-year follow-up. Helicobacter. 2010 Feb;15(1):46-52. doi: 10.1111/j.1523-5378.2009.00734.x.'}, {'pmid': '23567104', 'type': 'BACKGROUND', 'citation': 'Benajah DA, Lahbabi M, Alaoui S, El Rhazi K, El Abkari M, Nejjari C, Amarti A, Bennani B, Mahmoud M, Ibrahimi SA. Prevalence of Helicobacter pylori and its recurrence after successful eradication in a developing nation (Morocco). Clin Res Hepatol Gastroenterol. 2013 Nov;37(5):519-26. doi: 10.1016/j.clinre.2013.02.003. Epub 2013 Apr 6.'}, {'pmid': '22350696', 'type': 'BACKGROUND', 'citation': 'Take S, Mizuno M, Ishiki K, Imada T, Okuno T, Yoshida T, Yokota K, Oguma K, Kita M, Okada H, Yamamoto K. Reinfection rate of Helicobacter pylori after eradication treatment: a long-term prospective study in Japan. J Gastroenterol. 2012 Jun;47(6):641-6. doi: 10.1007/s00535-012-0536-9. Epub 2012 Feb 17.'}, {'pmid': '10372933', 'type': 'BACKGROUND', 'citation': 'Archimandritis A, Balatsos V, Delis V, Manika Z, Skandalis N. "Reappearance" of Helicobacter pylori after eradication: implications on duodenal ulcer recurrence: a prospective 6 year study. J Clin Gastroenterol. 1999 Jun;28(4):345-7. doi: 10.1097/00004836-199906000-00012.'}], 'seeAlsoLinks': [{'url': 'http://www.cdyfy.com/', 'label': 'the First Affiliated Hospital of Nanchang University'}]}, 'descriptionModule': {'briefSummary': 'Helicobacter pylori is closely related with gastritis, peptic ulcer, gastric cancer and gastric MALT lymphoma, and it may participate in a variety of parenteral diseases. Infection rates of Helicobacter pylori is still high, so effectively eradication is necessary. At present, the eradication therapy has achieved very good curative effect. However, relapse after eradication is unoptimistic. This study has made an analysis for reinfection after eradication of Helicobacter pylori Infection include the retrospective and prospective studies, aims to explore the epidemiological data and related risk factors of Hp reinfection in China.', 'detailedDescription': "In the retrospective study,we choose the people received regular eradication therapy, successfully eradicated helicobacter pylori more than six months, but 4 to 8 weeks after drug withdrawal ,the detection result of helicobacter pylori were negative to ensure that the results of the study is the reinfection, not residual. Even more noteworthy is during the treatment and detection again, the patients must not received any eradication therapy of Hp. What's more , before the detection, they also has not used antibiotics, bismuth agent and the traditional Chinese medicine with antibacterial effect in 1 monthor and has not used H2RA and PPI in 2 weeks to prevent affecting the accuracy of the results. At the same time, we also investigated the patient's general situation, conomic conditions, living conditions, personal health and lifestyle to explore related risk factors of Hp reinfection in China. In the prospective study, we detected Hp by C-UBT after regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months to prospect the reinfection of Hp.It also can make up the defects of retrospective study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In the retrospective study,people who has infected helicobacter pylori and successfully eradicated it more than six months detected helicobacter pylori by the C-urea breath test in order to evaluate the reinfection In the prospective study,people who has infected helicobacter pylori received regular eradication therapy after the 4 weeks, 8 weeks and 6 months detected helicobacter pylori by the C-urea breath test in order to prospect the reinfection', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n-1、Retrospective study：\n\n1. Received regular eradication therapy, 4 to 8 weeks after drug withdrawal , detected of helicobacter pylori and the results were negative\n2. Eradication program and original disease is unlimited\n3. Without any eradication therapyof Hp during the treatment and detection again\n4. before the detection has not used antibiotics, bismuth agent and the traditional Chinese medicine with antibacterial effect in 1 monthor and has not used H2RA and PPI in 2 weeks.\n\n2、Prospective study\n\n1. Infected with H. pylori that detected by C-UBT\n2. With out alimentary tract hemorrhage,ulceration and complications of eradication\n3. Eradication program and original disease is unlimited\n\nExclusion Criteria:\n\n1. Pregnancy or breast-feeding women\n2. With the major disease which would influence the research such as liver disease, heart disease, kidney disease, malignant tumor and alcohol poisoning\n3. Participated in other drug research in the past three months\n4. The patient can't express himself correctly such as mental illness and severe neurosis and can't cooperation this test"}, 'identificationModule': {'nctId': 'NCT02674802', 'acronym': 'RAEHPI', 'briefTitle': 'Reinfection After Eradication of Helicobacter Pylori Infection', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Nanchang University'}, 'officialTitle': 'Reinfection After Eradication of Helicobacter Pylori Infection in Adult :A National Multicentre Study', 'orgStudyIdInfo': {'id': 'Affiliated Hospital of NCU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective study', 'description': 'People who has successfully eradicated helicobacter pylori more than six months detected helicobacter pylori by the C-urea breath test in order to evaluate the reinfection.'}, {'label': 'Prospective study', 'description': 'People who has infected helicobacter pylori received regular eradication therapy after the 4 weeks, 8 weeks and 6 months detected helicobacter pylori by the C-urea breath test in order to prospect the reinfection .'}]}, 'contactsLocationsModule': {'locations': [{'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Nonghua Lv, MD', 'role': 'CONTACT', 'email': 'lunonghua@163.com', 'phone': '13707086809'}, {'name': 'Kunhe Zhang, MD', 'role': 'CONTACT', 'email': '393467260@qq.com', 'phone': '13007202818'}, {'name': 'Nonghua Lv, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'centralContacts': [{'name': 'Ying Huang, MD', 'role': 'CONTACT', 'email': '497514037@qq.com', 'phone': '15270953973'}, {'name': 'Yong Xie, MD', 'role': 'CONTACT', 'email': 'xieyong_med@163.com', 'phone': '13177893950'}], 'overallOfficials': [{'name': 'Nonghua Lv, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Nanchang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician-in-charge', 'investigatorFullName': 'Lingyu Luo', 'investigatorAffiliation': 'The First Affiliated Hospital of Nanchang University'}}}}