Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 7:30 AM
Study NCT ID:
NCT07045857
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recurrence of H Pylori : Incidence and Influential Factors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence of H. Pylori infection in patients who recieved medical treatment', 'timeFrame': '4 weeks after successful medical treatment', 'description': 'H. Pylori antigen in stool'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['H. Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '9453484', 'type': 'BACKGROUND', 'citation': 'Mitchell HM, Hu P, Chi Y, Chen MH, Li YY, Hazell SL. A low rate of reinfection following effective therapy against Helicobacter pylori in a developing nation (China). Gastroenterology. 1998 Feb;114(2):256-61. doi: 10.1016/s0016-5085(98)70475-5.'}, {'pmid': '7548807', 'type': 'BACKGROUND', 'citation': 'Chen TS, Tsay SH, Chang FY, Lee SD. Triple therapy for the eradication of Helicobacter pylori and reduction of duodenal ulcer relapse: comparison of 1 week and 2 week regimens and recrudescence rates over 12 months. J Gastroenterol Hepatol. 1995 May-Jun;10(3):300-5. doi: 10.1111/j.1440-1746.1995.tb01097.x.'}, {'pmid': '24914323', 'type': 'BACKGROUND', 'citation': 'Anand PS, Kamath KP, Anil S. Role of dental plaque, saliva and periodontal disease in Helicobacter pylori infection. World J Gastroenterol. 2014 May 21;20(19):5639-53. doi: 10.3748/wjg.v20.i19.5639.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine recurrence rates, identify influential factors, investigate key factors that contribute to recurrence, evaluate treatment effectiveness and to assess the efficacy of different eradication regimens and their role in reducing recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-75 years old.\n* H. pylori infection: Confirmed by endoscopy, biopsy, or non-invasive tests (e.g., urea breath test, stool antigen test).\n* Symptoms: Presence of dyspepsia, peptic ulcer disease, or other H. pylori-related symptoms.\n* Laboratory tests: Normal liver and kidney function, and no significant abnormalities in blood counts.\n\nExclusion Criteria:\n\n* Patients receiving eradication therapy in the past taking proton pump inhibitors,, H2 blockers ,,bismuth ,, antibiotics or other medications that interfere with the result of the examination in the recent 4 weeks.\n* Gastrointestinal disorders: Severe gastrointestinal disorders (e.g., gastric cancer, inflammatory bowel disease ,gastric or duodenal ulcer with current or recent bleeding , or clinical significant gastrointestinal bleeding within 4 weeks of randomization).\n* Malignancies: Active or recent malignancies.\n* Severe comorbidities: Unstable or severe comorbidities (e.g., heart failure, liver cirrhosis).'}, 'identificationModule': {'nctId': 'NCT07045857', 'briefTitle': 'Recurrence of H Pylori : Incidence and Influential Factors.', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Recurrence of H Pylori : Incidence and Influential Factors in Sohag Government.', 'orgStudyIdInfo': {'id': 'Soh-Med--25-5-11MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence', 'description': 'follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence and influential factors for recurrence', 'interventionNames': ['Behavioral: follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence']}], 'interventions': [{'name': 'follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence', 'type': 'BEHAVIORAL', 'description': 'follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence and influential factors for recurrence', 'armGroupLabels': ['follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT', 'phone': '01090801900'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Thomas W Thabet, Resident', 'role': 'CONTACT', 'email': 'thomaswagih0@gmail.com', 'phone': '01286046059'}, {'name': 'Usama M Abdelaal, Professor', 'role': 'CONTACT', 'phone': '01065962094'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident, Internal Medicine Department, Faculty of Medicine, Sohag University', 'investigatorFullName': 'Tomas Wagih Thabet', 'investigatorAffiliation': 'Sohag University'}}}}