Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-28 @ 6:33 PM
Study NCT ID:
NCT06026020
Status:
RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pathogenesis of Intestinal Behcet's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001528', 'term': 'Behcet Syndrome'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-03', 'studyFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2023-09-03', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Structure and composition of gut microbiota', 'timeFrame': 'Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)', 'description': 'DNA extraction from stool samples will be tested through 16S microbial sequencing and metagenomic sequencing to establish and compare microbial profiles of the gut microbiota among different groups.'}, {'measure': 'Structure and composition of oral microbiota', 'timeFrame': 'Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)', 'description': 'DNA extraction from saliva samples will be tested through 16S microbial sequencing and metagenomic sequencing to establish and compare microbial profiles of the oral microbiota among different groups.'}, {'measure': 'Structure and composition of metabolomics', 'timeFrame': 'Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)', 'description': 'Serum extraction from blood samples will be tested through non-targeted metabolomics techniques to analysis and compare metabolomics among different groups.'}, {'measure': 'Serum level of Immunoglobulin E', 'timeFrame': 'Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)', 'description': 'Serum extraction from blood samples will be used to test and compare the level of IgE among different groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Behcet's syndrome", "intestinal Behcet's syndrome", 'inflammatory bowel disease', 'microbiome', 'metabolomics'], 'conditions': ["Behcet's Syndrome, Intestinal Type"]}, 'descriptionModule': {'briefSummary': "There is a direct interaction between food, intestinal flora and the intestinal barrier composed of intestinal epithelial cells and mucosal immunity, whose composition and functional alterations are theorized to be closely related to the development of gastrointestinal (GI) involvement in Behcet's syndrome (BS) patients. Therefore, this study focuses on the population of patients with intestinal BS and explores the unique mechanisms leading to intestinal involvement in BS patients in terms of the characteristics of intestinal microecology. Since oral ulcers are one of the most common clinical manifestations in BS patients, in addition to intestinal flora analysis, this application project also plans to collect saliva samples from patients in the hope of obtaining a holistic understanding of mucosal flora in different parts of the entire GI tract. Serological testing and analysis will also be performed, focusing on changes in the intestinal tract and serum IgE levels, and analyzed in conjunction with microbiomics to provide evidence to further elucidate the pathogenesis of BS and GI involvement, and to search for more efficient therapeutic strategies, in terms of a variety of aspects, including clinical manifestations and disease progression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patient who have Behcet's syndrome with or without intestinal involvement, compared with inflammatory bowel disease patients and health controls.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nBehcet's syndrome patients with intestinal involvement:\n\n* Attendance at Peking Union Medical College Hospital, fulfillment of one of the two diagnostic criteria for BS (1990 Criteria of International Study Group for Behcet's disease or 2014 International Criteria for Behçet's Disease), and well-documented medical records;\n* Age 20-65 years old;\n* Have evidence of GI involvement, including clinical manifestations, laboratory tests, endoscopy, imaging and pathology;\n* Signed written informed consent and willingness to cooperate.\n\nBehcet's syndrome patients with intestinal involvement:\n\n* Attendance at Peking Union Medical College Hospital, fulfillment of one of the two diagnostic criteria for BS (1990 Criteria of International Study Group for Behcet's disease or 2014 International Criteria for Behçet's Disease), and well-documented medical records;\n* Age 20-65 years old;\n* Have no evidence of GI involvement, including clinical manifestations, laboratory tests, endoscopy, imaging and pathology;\n* Signed written informed consent and willingness to cooperate.\n\nInflammatory bowel disease patients:\n\n* Attended Peking Union Medical College Hospital and was diagnosed with Crohn's disease by a combination of clinical, imaging, and pathologic diagnosis;\n* Age 20-65 years old;\n* Signed written informed consent and willingness to cooperate.\n\nHealth controls:\n\n* Healthy individuals aged 20-65 years;\n* Signed written informed consent and willingness to cooperate.\n\nExclusion Criteria:\n\n* Other systemic diseases, such as autoimmune diseases, infectious diseases, malignant tumors, etc;\n* Patients with other intestinal diseases, such as intestinal tumors, intestinal tuberculosis, intestinal infections;\n* Patients with other oral diseases, such as cavity caries, oral abscesses, oral tumors, oral candidiasis, and dry mouth;\n* Patients taking antibiotics and probiotics within one month."}, 'identificationModule': {'nctId': 'NCT06026020', 'briefTitle': "Pathogenesis of Intestinal Behcet's Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': "Exploration of the Pathogenesis of Intestinal Behcet's Syndrome: a Single-center Prospective Observational Study", 'orgStudyIdInfo': {'id': 'K4434'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Behcet's syndrome patients with intestinal involvement", 'interventionNames': ['Other: Biological samples collection']}, {'label': "Behcet's syndrome patients without intestinal involvement", 'interventionNames': ['Other: Biological samples collection']}, {'label': 'Inflammatory bowel disease patients', 'interventionNames': ['Other: Biological samples collection']}, {'label': 'Health control', 'interventionNames': ['Other: Biological samples collection']}], 'interventions': [{'name': 'Biological samples collection', 'type': 'OTHER', 'description': 'Samples of blood, faeces, saliva are collected for analysis.', 'armGroupLabels': ["Behcet's syndrome patients with intestinal involvement", "Behcet's syndrome patients without intestinal involvement", 'Health control', 'Inflammatory bowel disease patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dong Wu', 'role': 'CONTACT', 'email': 'wudong@pumch.cn', 'phone': '18612671010'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Dong Wu', 'role': 'CONTACT', 'email': 'wudong@pumch.cn', 'phone': '18612671010'}], 'overallOfficials': [{'name': 'Dong Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}