Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT06117956
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Helicobacter Pylori in Patients With Chronic Tonsillits Prepared for Tonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-04', 'releaseDate': '2025-08-18'}], 'estimatedResultsFirstSubmitDate': '2025-08-18'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positive or negative h pylori infection in tonsillar tissue after tonsillectomy', 'timeFrame': '6 months', 'description': 'Tonsillectomy will be done with the dissection method and one tonsil per patient will be collected. A 2 mm gross specimen will be washed with normal saline. The specimen will be placed in a test tube well containing Rapid Urease Enzyme (GASTRO CURE SYSTEM RUT DRY TEST Batch No. A1060).\n\nThe initial color will be read at 0 min. Subsequent color changes will be read at 30 min, 6 hours, and 24 hours. Any color change from the initial yellow color to either pink or red will be recorded as positive. Any test that will be remained yellow after 24 hours will be recorded as negative. No readings will be taken after 24 hours.\n\nHistopathology:\n\nTonsillar tissue samples will be fixed in 10% formalin for 24 h. Each slide will be separately evaluated for the presence or absence of Helicobacter-like organisms at a high-power magnification'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Helicobacter Pylori Infection in Patients With Chronic Tonsillits']}, 'descriptionModule': {'briefSummary': "Tonsillar disorders are frequent In both pediatric and adult otolaryngological practice, . Numerous disorders that damage tonsillar tissue necessitate tonsillectomy. Tonsillectomy is typically required for recurrent tonsillitis. (Mani et al., 2019).\n\nAccording to studies, the mucosa-associated lymphoid tissue (MALT) of the stomach and tonsillar tissue in the Waldeyer's ring are both lymphoid tissues (Ma et al., 2018).\n\nOne of the most prevalent and frequent conditions in otorhinolaryngology is chronic tonsillitis, which is mostly brought on by bacterial infection. Chronic tonsillitis attacks can affect not only the tonsillar tissue but also can contribute to the emergence and progression of systemic disorders (Alrayah.,2023).\n\nA gram-negative, urease-producing bacterium called Helicobacter pylori colonizes the mucosa of the digestive tract. It has been linked to gastric malignancies, notably mucosa-associated lymphoid tissue (MALT) lymphoma, as well as gastric ulcers and duodenal ulcers (Kusters et al., 2006)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 5 to 50 years.\n2. Of both sex.\n3. Diagnosed with chronic tonsillitis undergoing elective tonsillectomy\n\nExclusion Criteria:\n\n1. Patients on proton pump inhibitor or antibiotics 2 weeks before surgery .\n2. Immune-compromised patients.\n3. Patients with obstructive sleep apnea candidates for adenotonsillectomy'}, 'identificationModule': {'nctId': 'NCT06117956', 'briefTitle': 'Helicobacter Pylori in Patients With Chronic Tonsillits Prepared for Tonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Helicobacter Pylori in Patients With Chronic Tonsillits Prepared for Tonsillectomy', 'orgStudyIdInfo': {'id': 'soh-Med-23-10-06 MS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rapid urease test for h pylori', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['histopathological study for removed tonsillar tissue after tonsillectomy'], 'description': 'Tonsillectomy will be done with the dissection method and one tonsil per patient will be collected. A 2 mm gross specimen will be washed with normal saline. The specimen will be placed in a test tube well containing Rapid Urease Enzyme (GASTRO CURE SYSTEM RUT DRY TEST Batch No. A1060).\n\nThe initial color will be read at 0 min. Subsequent color changes will be read at 30 min, 6 hours, and 24 hours. Any color change from the initial yellow color to either pink or red will be recorded as positive. Any test that will be remained yellow after 24 hours will be recorded as negative.\n\nTonsillar tissue samples will be fixed in 10% formalin for 24 h Each slide will be separately evaluated for the presence or absence of Helicobacter-like organisms at a high-power magnification'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'mohamed f fathy, resident', 'role': 'CONTACT', 'email': 'mohamed-fathy-post@med.sohag.edu.eg', 'phone': '01029578650'}, {'name': 'Mohamed a abdel kader, professor', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident- ENT DEPARTEMENT SUGAR COMPANY HOSPITAL', 'investigatorFullName': 'Mohamed Fathy Abdelsattar', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-18', 'type': 'RELEASE'}, {'date': '2025-09-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mohamed Fathy Abdelsattar, Resident- ENT DEPARTEMENT SUGAR COMPANY HOSPITAL, Sohag University'}}}}