Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 10:01 AM
Study NCT ID:
NCT05874960
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2023-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helicobacter Pylori Prevalence in Southern Region of Romania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016481', 'term': 'Helicobacter Infections'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Stool specimen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 708}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2023-05-16', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helicobacter pylori infection rate', 'timeFrame': '12 months', 'description': 'rate of fecal antigen test divided by total number of tests (fecal Helicobacter test)'}], 'secondaryOutcomes': [{'measure': 'Antibiotic susceptibility rate', 'timeFrame': '12 months', 'description': 'rate of antibiotic (x) susceptibility divided by total number of tests (antibiotic susceptibility test)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infections, Helicobacter']}, 'descriptionModule': {'briefSummary': 'Observational study, voluntary participation, 12 months, studying Helicobacter pylori prevalence.', 'detailedDescription': 'Observational study, voluntary participation, 12 months, studying Helicobacter pylori prevalence.\n\nThe aim of the study is to evaluate the prevalence of H. pylori infection in several areas of the Southern Regions of Romania, considered as vulnerable pertaining to the access of health services.\n\nFecal Helicobacter pylori will be tested, together with antibiotic susceptibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult population from Southern Regions of Romania, from rural vulnerable areas concerning access to health services.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult voluntary participants to "Medical services caravan" project by Medcorp Association\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT05874960', 'acronym': 'HELIUM', 'briefTitle': 'Helicobacter Pylori Prevalence in Southern Region of Romania', 'organization': {'class': 'OTHER', 'fullName': 'Carol Davila University of Medicine and Pharmacy'}, 'officialTitle': 'Helicobacter Pylori Prevalence in Southern Region of Romania', 'orgStudyIdInfo': {'id': 'HELIUM'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bucharest', 'country': 'Romania', 'facility': 'Medcorp Association', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Radu Prodan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medcorp Association'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carol Davila University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mihai Ciocirlan', 'investigatorAffiliation': 'Carol Davila University of Medicine and Pharmacy'}}}}