Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT05183256
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2021-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cohort of Inflammatory Bowel Disease Patient in Yeouido St. Mary's Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples are collected to assess the severity of IBD. Tissue samples through colonoscopy biopsy and stool samples are collected to find out gut flora through DNA analysis. No human DNA analysis is targeted.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with the remission of disease activity.', 'timeFrame': 'through study completion, an average of 2 year', 'description': "Disease activity is assessed in a clinical, endoscopic, and biochemical way. Each activity is determined by the Mayo score (in UC), Crohn's Disease Activity Index (in CD), Ulcerative Colitis Endoscopic Index of Severity (in UC), Simple Endoscopic Score for Crohn Disease (in CD), and biochemical findings (e.g. fecal calprotectin)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease'], 'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '30989166', 'type': 'RESULT', 'citation': 'Park SH, Kim YJ, Rhee KH, Kim YH, Hong SN, Kim KH, Seo SI, Cha JM, Park SY, Jeong SK, Lee JH, Park H, Kim JS, Im JP, Yoon H, Kim SH, Jang J, Kim JH, Suh SO, Kim YK, Ye BD, Yang SK; Songpa-Kangdong Inflammatory Bowel Disease [SK-IBD] Study Group. A 30-year Trend Analysis in the Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District of Seoul, Korea in 1986-2015. J Crohns Colitis. 2019 Oct 28;13(11):1410-1417. doi: 10.1093/ecco-jcc/jjz081.'}, {'pmid': '25083986', 'type': 'RESULT', 'citation': 'Dalal SR, Chang EB. The microbial basis of inflammatory bowel diseases. J Clin Invest. 2014 Oct;124(10):4190-6. doi: 10.1172/JCI72330. Epub 2014 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'Pathologically Inflammatory bowel disease (IBD) is in chronic complex inflammatory gut pathological condition. Although the etiology of IBD is unknown, gut microbiota alteration (dysbiosis) is considered a novel factor involved in the pathogenesis of IBD. The aim of this study is to analyze gut microbiota in IBD patients.', 'detailedDescription': "Inflammatory bowel disease (IBD) (Crohn's disease (CD) and ulcerative colitis (UC)) occurs worldwide with differences in epidemiology, etiology, and phenotype between regions. Pathologically Inflammatory bowel disease (IBD) is in chronic complex inflammatory gut pathological condition. Although the etiology of IBD is unknown, gut microbiota alteration (dysbiosis) is considered a novel factor involved in the pathogenesis of IBD. The DNA of microbiota will be investigated with samples of stool, colon tissue. The aim is to establish a cohort group for IBD (1), to make a database on cohort group characteristics such as endoscopic findings, disease severity, epidemiology, and prognosis (2), to analyze gut flora in IBD patients (3)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All consecutive patients with IBD, presented to division of gastroenterology, Yeouido St.Mary's hospital, will be asked to participate in this study.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The below 3 conditions must be met simultaneously.\n\n 1. Patient who can voluntarily consent to this study.\n 2. Patient who has inflammatory bowel disease.\n 3. Patient who is aged less than 75 years.\n\nExclusion Criteria:\n\n* a patient meets any of the below conditions.\n\n 1. If a patient has an IBD other than UC and CD.\n 2. If a patient is vulnerable due to his/her position as an employee of Yeouido St.Mary's hospital or a medical student of the Catholic University of Korea.\n 3. If a patient is pregnant.\n 4. Foreign personal who cannot speak Korean."}, 'identificationModule': {'nctId': 'NCT05183256', 'briefTitle': "Cohort of Inflammatory Bowel Disease Patient in Yeouido St. Mary's Hospital", 'organization': {'class': 'OTHER', 'fullName': "Yeouido St. Mary's Hospital"}, 'officialTitle': "Development of the Cohort of the Patients With Inflammatory Bowel Disease in Yeouido St. Mary's Hospital", 'orgStudyIdInfo': {'id': 'SC20TISI0103'}}, 'contactsLocationsModule': {'locations': [{'zip': '07241', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Yeouido St. Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ilsoo Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Yeouido St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Yeouido St. Mary's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ilsoo Kim, MD', 'investigatorAffiliation': "Yeouido St. Mary's Hospital"}}}}