[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537533":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":10,"locations":24,"responsibleParty":56,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":10,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Bonn","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GCA Patients",null,"Primary diagnosis of giant cell arteritis",[13],"Diagnostic Test: Analysis of blood and microbiome samples (stool, oral lavage)",{"label":15,"type":10,"description":16,"interventionNames":17},"Control","Control group without rheumatologic disease",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Analysis of blood and microbiome samples (stool, oral lavage)","Analysis of blood and microbiome samples (stool, oral lavage) especially composition of the gut microbiome and potential interaction with immune cells",[15,9],[25,45],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn","RECRUITING","Bonn","North Rhine-Westphalia","53127","Germany","DE",{"type":34,"coordinates":35},"Point",[36,37],7.09549,50.73438,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":43,"phoneExt":10,"email":44},"Valentin S. Schäfer, Dr. med.","CONTACT","+49 228 287-17000","rheumatologie@ukbonn.de",{"facility":46,"status":27,"city":28,"state":10,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":47,"geoPoint":49,"contacts":50},"University Hospital Bonn",{"type":34,"coordinates":48},[36,37],{"lat":37,"lon":36},[51,54],{"name":52,"role":42,"phone":53,"phoneExt":10,"email":44},"Valentin Schäfer, MD","+28 287 17000",{"name":55,"role":42,"phone":53,"phoneExt":10,"email":44},"Maike Adamson",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Valentin Schäfer","Head of the rheumatology department, University Hospital Bonn","100537533","investigation-of-the-influence-of-the-human-microbiome-on-giant-cell-arteritis-100537533",false,"NCT06279065","Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis","Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis","GCA-Biom","Inclusion Criteria:\n\n• Diagnosis of Giant cell arteritis (only in one arm)\n\nExclusion Criteria:\n\n* chronic infection (viral, fungi, bacteria) including human immunodeficiency viruses, Hepatitis B\u002FC\n* acute infection with usage of antibiotics less then 90 days before screening\n* major gastro-intestinal surgery \\\u003C5 years from screening\n* gastro-intestinal bleeding \\\u003C90 days before screening\n* inflammatory bowel disease (confirmed bioptically)\n* bulimia or anorexia nervosa\n* adipositas (body mass index ≥ 40)\n* intake of high dosage of probiotics (\\>10\\^9 colony forming units per day) \\\u003C90 days before screening\n* not controlled Diabetes mellitus\n* Malignancy within one year (except for squamous skin - and basal skin carcinoma without metastasis, cervix carcinoma with curative surgery, Cutaneous T-cell lymphoma)\n* known abuse of alcohol oder drugs.",true,"ALL","18 Years",{"count":72,"type":73},50,"ESTIMATED","OBSERVATIONAL","The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (abbr. GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate biota will be further analyzed for possible interactions and influence on the immune system.",[77],"Giant Cell Arteritis",[79],"microbiome","2024-05-07",{"date":82,"type":83},"2024-05-09","ACTUAL",{"date":85,"type":83},"2024-02-29",{"date":87,"type":73},"2028-02",{"name":5,"class":6},2]