vasculitis
Conditions
Interventions
Niet van toepassing
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • All individuals with a disease that could lead to vasculitis (amongst others: ANCA vasculitides, systemiuc lupus erythematodes (SLE), systemic sclerosis, Sjögren’s disease, IgA-nephropathy, polyarteritis nodosa (PAN), Behçet's disease), visiting the outpatient clinic of Amsterdam UMC region are potentially eligible if theyare >18 years old • Disease diagnosis is made by clinician. Vasculitis subtype will be recorded along with the presence of auto-antibodies at time of diagnosis and during remission (where applicable, e.g., in the case of AAV)
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Active infection at the time of inclusion (not to influence immune-cell function) • Unwillingness to donate feces, urine and/or blood • Inability to provide informed consent based on cognitive function, language barrier or other reasons • Absence of large bowel (i.e., colostomy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: Gut microbiota (oral and fecal) and nasal microbiota composition in relation to autoimmunity status (antibodies and HLA subtype) and circulating immune cell (functional) assays in patients with an autoimmune disease potentially leading to vasculitis, also copmared to healthy controls (if applicable). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Treatment efficacy (as determined by change in inflammatory parameters, time to relapse, disease-specific activity index) • Questionnaires about abdominal complaints and antibiotics use during life • Efficacy of medication in relation to microbiota changes as well as on circulating immune cells (flow cytometry and functional assays) and plasma metabolites • HLA type by high resolution sequencing of circulating neutrophils; from the literature it is known that certain HLA high-risk alleles may act as an effect modifier on the association between microbiota and disease severity. Since carriership of certain HLA alleles is also associated with outcome of disease (16, 17), we will include this variable into statistical models to determine the association of HLA alleles, disease severity with microbiota and metabolites. • Body composition as measured by impedance, with that the risk for developing corticosteroid related complications • Pathophysiology and development of cardiovascular events (defined as: myocardial infarction, hospitalization for unstable angina, hemorrhagic and ischemic cerebrovascular event, transient ischemic attacks and arterial revascularization procedures) after 1, 5 and 10 years after inclusion. | — |
Countries
Netherlands
Contacts
Public ContactM.L. Hilhorst
Amsterdam UMC
Outcome results
None listed