Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-05 @ 6:27 PM
Study NCT ID:
NCT04959435
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding the Role of Oral Microbiota in Behçet's Disease (BEHCETBIOT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001528', 'term': 'Behcet Syndrome'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2021-07-02', 'studyFirstSubmitQcDate': '2021-07-02', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral microbiota', 'timeFrame': 'Day 0', 'description': "Establish microbial profiles (quantitative and qualitative via analysis of bacterial DNA sequences encoding 16S rRNA) of dental plaque, pathological (on the aphta) and non-pathological oral mucosa and and salivary and compared them to control without Behçet's disease matched for sex, diet and socio-cultural level."}], 'secondaryOutcomes': [{'measure': 'Intestinal microbiota', 'timeFrame': 'Day 0', 'description': "Establish microbial profiles (quantitative and qualitative via analysis of DNA sequences encoding 16S rRNA) of the intestinal microbiota by studying feces and comparing them to controls without Behçet's disease, of the same sex, diet and socio-cultural level"}, {'measure': 'Short fatty acid', 'timeFrame': 'Day 0', 'description': "Determination of short-chain fatty acids (HPLC technique) in the stools of Behçet patients and compare them to control patients without Behçet's disease, of the same sex, diet and socio-cultural level"}, {'measure': 'Pro-inflammatory cytokines', 'timeFrame': 'Day 0', 'description': 'Determination of blood and saliva levels of IL-1beta, IL-6, IL-17, IL21, IL-23, Il-10, IFN gamma and TNF alpha (ELISA technique or multiplexed assay) and compare them to patients without Behçet disease, of the same sex, diet and socio-cultural level.\n\nsocio-cultural level'}, {'measure': 'genital microbiota', 'timeFrame': 'Day 0', 'description': "Establish microbial profiles (quantitative and qualitative via analysis of DNA sequences encoding 16S rRNA) of the intestinal microbiota by studying feces and comparing them to controls without Behçet's disease, of the same sex, diet and socio-cultural level"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Behçet Disease', 'Physiopathology', 'Microbiota', 'Oral Microbiota']}, 'descriptionModule': {'briefSummary': "Behçet's disease (BD) is a systemic vasculitis that affects, especially, young people.\n\nAlthough its etiology remains unexplained, data suggest that the inflammatory response during BD results from a disruption of the homeostasis of innate and adaptive immune responses in genetically predisposed people. The microbiota could play a triggering role in BD, in particular the salivary and dental plaque microbiota. The aim of the Behçetbiot study is therefore to establish microbial profiles of dental plaque, pathological (on the mouth ulcer) and non-pathological mucous membrane, salivary and digestive and to compare them with control subjects not suffering from BD, related to the first degree, of the same socio-cultural level and to determine whether dysbiosis is correlated with a local and systemic pro-inflammatory response, by measuring salivary level of pro-inflammatory cytokines and blood level of CRP, fibrinogen, orosomucoïd and haptoglobin, and to compare them with controls.", 'detailedDescription': 'All patients and their controls are sampled for stool, saliva, dantal plaque, oral mucosa, genital mucosa and blood during an annual follow-up visit or if they are hospitalised.\n\nPlaque, oral mucosa, genital mucosa salivary and blood will be collected during an annual follow-up visit.\n\nFor stool samples, the collection material will be provided to the patient and they will be able to take the sample at home and bring it to the clinic, or send them via a carrier within 3 days.\n\nAll the samples related to the study will be taken in the internal medicine in Clermont-Ferrand (France) or Pitie Salpêtrière, department of internal medecine, Paris,France or ophthalmology departments in Clermont-Ferrand.\n\nAll sample will be stocked in biological center in Clermont-Ferrand before analyze.\n\nMicrobiota analyzes will be realise at M2iSH laboratoty, inflammatory cytokines will be analyze in Clermont-Ferrand immunology laboratory, and pro-inflammatory parameters will be analyse in biochimy laboratory in Clermont-Ferrand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patient who have behçet's disease.", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who meet the International criteria for the classification of Behçet's disease, revised in 2013)\n* Patient who had developed the disease in the 5 years preceding the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women, or women who may be pregnant or breastfeeding.\n* Subject placed under judicial protection.\n* Patient had received antibiotic or probiotic or symbiotic therapy in the 6 weeks preceding inclusion"}, 'identificationModule': {'nctId': 'NCT04959435', 'acronym': 'BEHCETBIOT', 'briefTitle': "Understanding the Role of Oral Microbiota in Behçet's Disease (BEHCETBIOT)", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': "Understanding the Role of the Salivary Microbiota and Microbiota Associated to Mucosa in Behçet's Disease", 'orgStudyIdInfo': {'id': 'RBHP 2021 ANDRE'}, 'secondaryIdInfos': [{'id': '2021-A01648-33', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': "Behcet's disease patients", 'interventionNames': ['Other: biological samples collection']}, {'label': 'Controls', 'description': 'Controls that matched two to two at case according to sex,social status and diet.', 'interventionNames': ['Other: biological samples collection']}], 'interventions': [{'name': 'biological samples collection', 'type': 'OTHER', 'description': 'samples of blood, faeces, saliva, dental plaque, oral mucosa, genital mucosa', 'armGroupLabels': ['Case', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital La Pitié Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Marc André', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data are reserved for M2ISH laboratory team .'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}