Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT05846061
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2023-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of Helicobacter Pylori Infection in Children From Slovenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'stool specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 430}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-06-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2023-04-25', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of infected children in different age population', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['children', 'infection'], 'conditions': ['Helicobacter Pylori Infection', 'Transmission']}, 'referencesModule': {'references': [{'pmid': '35285106', 'type': 'BACKGROUND', 'citation': 'Polivanova TV, Malaty H, Vshivkov VA. Epidemiology Helicobacter pylori infection in children in the Tyva Republic (Russia). Helicobacter. 2022 Jun;27(3):e12882. doi: 10.1111/hel.12882. Epub 2022 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'The epidemiology of H. pylori infection among children in Slovenia has not been investigated. Therefore, we are conducting a study to examine the epidemiology of H. pylori and associated risk factors among children in Slovenia.', 'detailedDescription': 'The population selection was from the three different geographic location in Slovenia. The selection of the studied places was based on their social and economic characteristics and medical provision. We included children from three age groups at the same time we collected information from the parents which may be important for H. pylori transmission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children from school of different age groups- community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 6, 14 and 17 years living in three different regions in Slovenia\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05846061', 'briefTitle': 'Epidemiology of Helicobacter Pylori Infection in Children From Slovenia', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Epidemiology of Helicobacter Pylori Infection in Children From Slovenia', 'orgStudyIdInfo': {'id': '07011968'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prevalence study population', 'description': 'prevalence study population', 'interventionNames': ['Other: Prevalence study population']}], 'interventions': [{'name': 'Prevalence study population', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Prevalence study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Matjaz Homan, MD PhD', 'role': 'CONTACT', 'email': 'matjaz.homan@guest.arnes.si', 'phone': '0038640885848'}, {'name': 'Nusa Cesar, MD', 'role': 'CONTACT', 'email': 'nusa.cesar@gmai.com', 'phone': '0038615229276'}, {'name': 'Polona Maver Vodičar, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Saša Simšič, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eva Mojškrc, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "University Children's Hospital in Ljubljana", 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of paediatrics', 'investigatorFullName': 'Tadej Battelino', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}