Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT05542368
Status:
UNKNOWN
Last Update Posted:
2022-09-15
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Thyroid Status in Patients With IBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013960', 'term': 'Thyroid Function Tests'}], 'ancestors': [{'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-14', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of thyroid disorders in patients with IBD', 'timeFrame': '1 year', 'description': 'By use of Thyroid function test (include T3-T4- TSH), thyroid antibodies and thyroid sonography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Disease', 'Irritable Bowel Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ejode.eg.net/article.asp?issn=2356-8062;year=2016;volume=2;issue=2;spage=67;epage=80;aulast=Ghitany', 'label': 'nflammatory bowel disease severity and activity are correlated to thyroid gland nodularity, chronic nonthyroidal illness, and thyroid autoantibodies but not thyroid dysfunction'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/3065074', 'label': 'Role of autoantibodies in the pathogenesis and association of endocrine autoimmune disorders'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/15897640/', 'label': "Autoimmune thyroid disease (Graves' disease and hashimoto's thyroiditis) in two patients with Crohn's disease: case reports and literature review"}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/11419852/', 'label': 'Simultaneous occurrence of inflammatory bowel disease and thyroid disease'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/1500669/', 'label': "Coexistence of Addison's disease, ulcerative colitis, hypothyroidism and pernicious anemia"}]}, 'descriptionModule': {'briefSummary': '. The aim of the present study is to study thyroid state in patients with IBD', 'detailedDescription': 'All patients were subjected to history taking and physical examination with emphasis on history of autoimmune disease, extraintestinal manifestations of IBD, neck examination for goiter, symptoms and signs of thyroid dysfunction.\n\nb) Laboratory investigations: Thyroid function test (include T3-T4- TSH)\n\n* ESR - CRP - thyroid antibodies: (Anti TPO -Anti Thyroglobulin)\n\n c)-Imaging:\n* Neck U/S on thyroid gland to identify patients with ultrasonographic evidence of autoimmune thyroiditis (diffuse hypoechogenicity or heterogenicity echotexture or both) and to detect thyroid nodularity.\n\nd ) Endoscopic findings regarding diagnosis of IBD confirmed by histopathological examination'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with IBD admitted at Assiut University Hospital, Al Rajhi Liver Hospital or attending IBD outpatient clinic.\n\na. Inclusion criteria: All patients with IBD Exclusion criteria: patients with\n\n* Thyroid disease\n* Acute or chronic kidney\n* Acute or Chronic Liver Disease. Active Lupus -\n* Malignancy\n* patients taking medications that affect thyroid function as rifampin, amiodarone', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: All patients with IBD\n\n\\-\n\nExclusion Criteria:\n\n* patients with\n* Thyroid disease\n* Acute or chronic kidney\n* Acute or Chronic Liver Disease. Active Lupus -\n* Malignancy\n* patients taking medications that affect thyroid function as rifampin, amiodarone …..'}, 'identificationModule': {'nctId': 'NCT05542368', 'briefTitle': 'Study of Thyroid Status in Patients With IBD', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Study of Thyroid State in Patients With Inflammatory Bowel Diseases', 'orgStudyIdInfo': {'id': 'thyroid state in IBD patients'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with IBD', 'description': 'All patients were subjected to history taking and physical examination with emphasis on history of autoimmune disease, extraintestinal manifestations of IBD, neck examination for goiter, symptoms and signs of thyroid dysfunction.\n\nb) Laboratory investigations: Thyroid function test (include T3-T4- TSH)\n\n* ESR - CRP - thyroid antibodies: (Anti TPO -Anti Thyroglobulin)\n\n c)-Imaging:\n* Neck U/S on thyroid gland to identify patients with ultrasonographic evidence of autoimmune thyroiditis (diffuse hypoechogenicity or heterogenicity echotexture or both) and to detect thyroid nodularity.\n\nd ) Endoscopic findings regarding diagnosis of IBD confirmed by histopathological examination', 'interventionNames': ['Diagnostic Test: Thyroid tests']}, {'label': 'Healty individuals as a control group', 'description': 'All patients were subjected to history taking and physical examination with emphasis on history of autoimmune disease, extraintestinal manifestations of IBD, neck examination for goiter, symptoms and signs of thyroid dysfunction.\n\nb) Laboratory investigations: Thyroid function test (include T3-T4- TSH)\n\n* ESR - CRP - thyroid antibodies: (Anti TPO -Anti Thyroglobulin)\n\n c)-Imaging:\n* Neck U/S on thyroid gland to identify patients with ultrasonographic evidence of autoimmune thyroiditis (diffuse hypoechogenicity or heterogenicity echotexture or both) and to detect thyroid nodularity.', 'interventionNames': ['Diagnostic Test: Thyroid tests']}], 'interventions': [{'name': 'Thyroid tests', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Thyroid function test and thyroid antibodies'], 'description': 'Thyroid function test TSH ,T3,T4 Thyroid antibody test anti TPO,antithyroglobulin', 'armGroupLabels': ['Healty individuals as a control group', 'Patients with IBD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Hassan, Resident', 'role': 'CONTACT', 'email': 'nisreenhassan6@gmail.com', 'phone': '+201144971296'}, {'name': 'Abu Bakr Elisily, professor', 'role': 'CONTACT', 'email': 'fatmaelosily@yahoo.com', 'phone': '+201006564000'}], 'overallOfficials': [{'name': 'Abo zaid Ali, assistant prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nesreen Hassan Mansour Ali', 'investigatorAffiliation': 'Assiut University'}}}}