Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis
Recruiting
- Conditions
- Giant Cell Arteritis
- Interventions
- Diagnostic Test: Analysis of blood and microbiome samples (stool, oral lavage)
- Registration Number
- NCT06279065
- Lead Sponsor
- University of Bonn
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
• Diagnosis of Giant cell arteritis (only in one arm)
Exclusion Criteria
- chronic infection (viral, fungi, bacteria) including human immunodeficiency viruses, Hepatitis B/C
- acute infection with usage of antibiotics less then 90 days before screening
- major gastro-intestinal surgery <5 years from screening
- gastro-intestinal bleeding <90 days before screening
- inflammatory bowel disease (confirmed bioptically)
- bulimia or anorexia nervosa
- adipositas (body mass index ≥ 40)
- intake of high dosage of probiotics (>10^9 colony forming units per day) <90 days before screening
- not controlled Diabetes mellitus
- Malignancy within one year (except for squamous skin - and basal skin carcinoma without metastasis, cervix carcinoma with curative surgery, Cutaneous T-cell lymphoma)
- known abuse of alcohol oder drugs.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description GCA Patients Analysis of blood and microbiome samples (stool, oral lavage) Primary diagnosis of giant cell arteritis Control Analysis of blood and microbiome samples (stool, oral lavage) Control group without rheumatologic disease
- Primary Outcome Measures
Name Time Method Significant differences in the composition of the microbiome At Baseline and 6 month follow up
- Secondary Outcome Measures
Name Time Method Influence of the microbiome on therapy response e.g. increased probability of recurrence with accumulation of specific microbiome species At Baseline and 2 year follow up potential association of microbiome composition with application of immune modulating drugs At Baseline and 6 month follow up
Trial Locations
- Locations (2)
Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn
🇩🇪Bonn, North Rhine-Westphalia, Germany
University Hospital Bonn
🇩🇪Bonn, Germany