Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-10 @ 1:34 PM
Study NCT ID:
NCT03968302
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADDITION OF BISMUTH TO THE STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'PARALLEL ASSIGNMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POST H PYLORI TREATMENT RESULTS', 'timeFrame': '2 months', 'description': 'The primary end point was post-treatment result after triple or quadruple therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['H pylori; eradication; amoxicillin; clarithromycin; esomeprazole; colloidal bismuth subcitrate'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'H pylori is an important cause of chronic gastritis and other complications. There is a decline in eradication rate for H pylori owing to multiple factors including drug resistance. We compare the effect of the addition of bismuth to the standard triple therapy in a randomized control trial.\n\nSubjects were randomized into two arms. Arm A received triple therapy including amoxicillin, clarithromycin, and omeprazole and Arm B received quadruple therapy adding colloidal bismuth subcitrate. Both arms received treatment for two weeks.', 'detailedDescription': 'The study is a 2-arm, prospective, randomized, non-inferiority, unblinded, parallel design trial. The primary end point is post-treatment result after triple or quadruple therapy. Secondary endpoints included the nature and frequency of side effects compared between the two arms. The study protocol was approved by the ethical review committee of the university.\n\nPatients with dyspeptic symptoms who had H pylori infection, diagnosed through positive Stool for H pylori antigen or presence of H. pylori organism in the histopathology of gastric mucosal biopsy, attending outpatient department of two campuses of the University Hospital were included in this study.. Group A received standard triple therapy for H. pylori eradication for a total 14 days and group B received bismuth-based quadruple therapy for H pylori eradication for the same period. The triple regimen was defined as a combination of amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose. Quadruple therapy included colloidal bismuth subcitrate 240 mg twice daily, in addition. H. Pylori status was checked routinely after 6 weeks by Stool sampling for H, pylori antigen. Subjects were counseled to stop taking PPI or any antibiotic 2 weeks before stool H. pylori antigen testing. Eradication of H pylori was defined as lack of detection of H pylori antigen in the stool via ELISA method after triple or quadruple therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients with dyspeptic symptoms who had H pylori infection, diagnosed through positive Stool for H pylori antigen or presence of H. pylori organism in the histopathology of gastric mucosal biopsy, attending outpatient department of two campuses of the University Hospital were included in this study\n\nExclusion Criteria:\n\nExclusion criteria were patients with age less than 12 years, age more than 80 years, recent antibiotic use, and treatment-experienced patients, where H. pylori couldn't eradicate after treatment, chronic illnesses with multiple comorbid for example, chronic liver disease, chronic kidney disease or terminal illness etc, pregnancy and allergy to any of the regimen components."}, 'identificationModule': {'nctId': 'NCT03968302', 'briefTitle': 'ADDITION OF BISMUTH TO THE STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION', 'organization': {'class': 'OTHER', 'fullName': 'Ziauddin University'}, 'officialTitle': 'ADDITION OF BISMUTH TO THE STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION: A RANDOMIZED CONTROLLED STUDY', 'orgStudyIdInfo': {'id': 'ZiauddinU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARM A', 'description': 'The triple regimen, amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole 40 mg twice a day', 'interventionNames': ['Drug: ARM A Triple therapy for helicobacter pylori']}, {'type': 'EXPERIMENTAL', 'label': 'ARM B', 'description': 'The quadruple regimen,amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day, omeprazole 40 mg twice a day dose and colloidal bismuth subcitrate 240 mg twice daily', 'interventionNames': ['Drug: ARM B Quadruple therapy for helicobacter pylori']}], 'interventions': [{'name': 'ARM A Triple therapy for helicobacter pylori', 'type': 'DRUG', 'description': 'The triple regimen was defined as a combination of amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose.', 'armGroupLabels': ['ARM A']}, {'name': 'ARM B Quadruple therapy for helicobacter pylori', 'type': 'DRUG', 'description': 'Quadruple therapy included colloidal bismuth subcitrate 240 mg twice daily,amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose.', 'armGroupLabels': ['ARM B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Ziauddin University Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'MUHAMMAD ASIM, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZIAUDDIN UNIVERSITY HOSPITAL'}, {'name': 'KHURRAM BAQAI, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziauddin University'}, {'name': 'ZAIGHAM ABBAS, FCPS', 'role': 'STUDY_CHAIR', 'affiliation': 'Ziauddin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziauddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'GI FELLOW', 'investigatorFullName': 'Muhammad Asim', 'investigatorAffiliation': 'Ziauddin University'}}}}