Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-28 @ 9:53 PM
Study NCT ID:
NCT05830357
Status:
UNKNOWN
Last Update Posted:
2023-04-26
First Post:
2023-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Risk Factors of Helicobacter Pylori Infection in Children and Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-05-10', 'releaseDate': '2023-12-05'}], 'estimatedResultsFirstSubmitDate': '2023-12-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'stool specimen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 667}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2023-04-14', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Studying prevalence of Helicobacter Pylori infection in children and young adults in Sohag governorate', 'timeFrame': '12 weeks following the startpoint of the study.', 'description': 'determine the prevalence of Helicobacter Pylori infection in children and young adults in Sohag governorate by examining stool samples from 667 patients to detect h.pylori antigen'}], 'secondaryOutcomes': [{'measure': 'detecting risk factors related to Helicobacter Pylori infection in children and young adults in sohag governorate', 'timeFrame': '12 weeks following the startpoint of the study', 'description': 'We will use a semi-structured questionnaire to detect helicobacter pylori risk factors which include the following : Socio-demographic data, personal habits, physical activity and exercises, history of symptoms suggesting helicopter pylori infection like episodes of epigastric pain, vomiting and dyspepsia and family history, medication and comorbidities .'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'dyspepsia', 'children', 'young adults', 'prevalence', 'peptic ulcer', 'risk factors'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'Helicobacter pylori is a gram-negative bacterium that resides in the stomach and can cause inflammation leading to long-term effects, such as gastric ulcers, cancer, and lymphoma of the stomach mucosal linings Previous research and analysis of H. pylori prevalence in populations have examined common risk factors that increase the likelihood of acquiring the bacteria. Some of the most commonly identified risk factors across various studies in different geographic populations are larger family size, less education, lower socioeconomic status, less frequent hygiene practices, and lower sanitation with specific emphasis on sources of water and defecation.\n\naim of the work: Studying prevalence of Helicobacter Pylori infection and its related risk factors in children and young adults in Sohag governorate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be chosen by random sampling technique among children and young adults (between 2 to 25 years old) attending internal medicine and pediatric out- patient clinics at Sohag University hospital.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children and young adults (between 2 to 25 years old)\n\nExclusion Criteria:\n\n* children below 2 years old\n* adults more than 25 years old'}, 'identificationModule': {'nctId': 'NCT05830357', 'briefTitle': 'Prevalence and Risk Factors of Helicobacter Pylori Infection in Children and Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Prevalence and Risk Factors of Helicobacter Pylori Infection in Children and Young Adults in Sohag Governorate', 'orgStudyIdInfo': {'id': 'Soh-Med-23-04-15MS'}}, 'contactsLocationsModule': {'locations': [{'zip': '093', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Maha Ayman Thabet', 'role': 'CONTACT', 'email': 'mahaayman@med.sohag.edu.eg', 'phone': '01556073331', 'phoneExt': '+20'}], 'facility': 'Faculty of medicine-Sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Maha Ayman Thabet', 'role': 'CONTACT', 'email': 'mahaayman@med.sohag.edu.eg', 'phone': '01556073331', 'phoneExt': '+20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'demonstrator at family medicine department', 'investigatorFullName': 'Maha Ayman Thabet', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-05', 'type': 'RELEASE'}, {'date': '2024-05-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Maha Ayman Thabet, demonstrator at family medicine department, Sohag University'}}}}