Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT06203158
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2023-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intestinal Epithelial Fucosylation Affects the Efficacy of Ustekinumab in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2023-12-20', 'studyFirstSubmitQcDate': '2024-01-02', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical remission rate at 24 week', 'timeFrame': 'at 24 week', 'description': "A specialist will evaluate the HBI score at 24 week based on the patient's clinical symptoms and determine whether the patient is in clinical remission based on the score."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['durg efficacy', "Crohn's Disease", 'Ustekinumab', 'Intestinal Epithelial Fucosylation'], 'conditions': ['IBD']}, 'descriptionModule': {'briefSummary': "The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Molecular markers that can accurately predict the efficacy of UST are urgently needed to provide theoretical basis for guiding individualized treatment. Therefore, this study intends to explore the impact of intestinal epithelial fucosylation levels on the efficacy of UST in patients with Crohn's disease(CD), aiming to provide predictable molecular markers for UST to accurately treat CD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Inflammatory bowel disease (IBD) is a chronic inflammatory disease involving the digestive tract, including two clinical phenotypes: Crohn's disease (CD) and ulcerative colitis (UC).", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosed with moderate to severe Crohn's disease\n2. Receiving treatment with ustekinumab\n3. Received colonoscopy and collected intestinal tissue samples before and after treatment\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Hypersensitivity to any component of ustekinumab\n3. Cognitive or developmental disabilities prevent you from completing this study\n4. Combined with diseases such as RA, diabetes, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis and tumors"}, 'identificationModule': {'nctId': 'NCT06203158', 'briefTitle': "Intestinal Epithelial Fucosylation Affects the Efficacy of Ustekinumab in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': "Intestinal Epithelial Fucosylation Affects the Efficacy of Ustekinumab in Crohn's Disease", 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2023-01-112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High fucosylation group', 'description': "Immunohistochemistry was used to detect the fucosylation level in the intestinal tissue biopsy of patients with Crohn's disease at baseline. The fucosylation level in the baseline intestinal tissue was higher than 50% of the total."}, {'label': 'Low fucosylation group', 'description': "Immunohistochemistry was used to detect the fucosylation level in the intestinal tissue biopsies of patients with Crohn's disease at baseline. The fucosylation level in the baseline intestinal tissue was less than 50% of the total."}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}