Rheumatoid arthritis, Sjögren’s syndrome, axial spondyloarthritis, and periodontitis.
Conditions
Interventions
Group 1: The planned study is designed to investigate non-invasive salivary biomarkers for rheumatoid arthritis (RA), Sjögren’s syndrome (SS), and axial spondyloarthritis (axSpA).
Study population: Pa
Sponsors
Praxis Dr. Niklas T. Baerlecken, Facharzt für Innere Medizin und Rheumatologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: For patients with rheumatic diseases (RA, SS, axSpA): Diagnosed rheumatoid arthritis, Sjögren’s syndrome, or axial spondyloarthritis according to internationally recognized classification criteria Age = 18 years Ability and willingness to provide written informed consent Provision of saliva samples Optional: ability and willingness to attend the scheduled study visits and undergo the standardized periodontal examination For healthy control participants: No known inflammatory rheumatic disease No known systemic autoimmune disease No ongoing rheumatological evaluation due to suspected RA, axSpA, or Sjögren’s syndrome Age = 18 years Comparable age and sex distribution Ability and willingness to provide written informed consent Provision of saliva samples Frequency-matched recruitment according to age and sex
Exclusion criteria
Exclusion criteria: For patients with rheumatic diseases and healthy control participants, exclusion criteria include acute infections or systemic diseases that significantly affect the immune system, such as HIV infection or hepatitis; antibiotic treatment within the previous four weeks that could alter the oral microbiota or autoantibody levels; severe systemic diseases, such as advanced cardiac, hepatic, or renal disease, that could impair participation or affect the interpretation of the study results; pregnancy or breastfeeding; inability to understand the study information or provide written informed consent; and participation in other clinical studies that could affect the immune response or oral microbiota. Acute infections, relevant systemic diseases, HIV infection, hepatitis B or hepatitis C, and an existing pregnancy will be assessed exclusively based on medical history using a standardized self-report questionnaire. No study-specific blood or urine tests will be performed to exclude these criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification and validation of non-invasive salivary biomarkers for rheumatoid arthritis (RA) through the analysis of associations between periodontitis-associated bacteria (P. gingivalis, A. actinomycetemcomitans), autoantibodies (ACPA, RF), and clinical parameters. The aim is to develop a multiparametric biomarker profile that can be used for the early diagnosis of RA and the assessment of disease activity. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Investigation of additional oral pathobionts, such as Fusobacterium nucleatum and Tannerella forsythia, in saliva and their potential interactions with autoantibodies and RA disease activity. 2. Correlation of the biomarker profile with clinical disease activity scores, including DAS28, CDAI, SDAI, ESSDAI, BASDAI, and ASDAS, to estimate disease activity. 3. Analysis of dietary factors and their influence on the oral microbiota, autoantibody concentrations, and inflammatory activity. 4. Identification of potentially novel salivary autoantibodies using protein arrays and subsequent verification by ELISA to expand the panel of diagnostic biomarkers. | — |
Countries
Germany
Contacts
Public ContactNiklas Thomas Baerlecken
Praxis Dr. Niklas T. Baerlecken, Facharzt für Innere Medizin und Rheumatologie
Outcome results
None listed