rheumatische aandoeningen Primary Sjögren's syndrome Sjögren
Conditions
Interventions
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, all subjects must meet all of the following criteria: • Age >= 18 years • Live in Groningen, Friesland or Drenthe • Signed informed consent;Subjects must meet the following criteria to be included in one of the four study groups: • Group 1: Confirmed diagnosis of pSS according to the AECG criteria [4] after complete diagnostic workup.;• Group 2: non-SS sicca. After complete diagnostic workup defined as: o Presence of symptoms of dry eyes and/or symptoms of a dry mouth according to the questions in the AECG criteria (supplement 15.1) o Negative minor salivary gland biopsy according to the Chisholm and Mason scoring system(30) o Absence of anti-Ro/La (SSA/SSB) auto-antibodies o Low clinical suspicion of pSS;• Group 3: Newly diagnosed SLE patients. After excluding alternative diagnoses, SLE is diagnosed in patients who fulfill the 1997 American College of Rheumatology (ACR) criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria. o Disease duration of a maximum of 1 year;• Group 4: Healthy controls from the LifeLines Deep cohort. Healthy is defined as: o No chronic illness of any kind (cardiovascular, cancer, renal / liver failure, etc. etc.) o No use of immunosuppressive medication
Exclusion criteria
Exclusion criteria: A potential subject for the Sjögren Microbiome study who meets any of the following criteria will be excluded from participation: * Presence of other systemic auto-immune connective tissue disease than SS or SLE (i.e., RA or systemic sclerosis) * Presence of IgG4-related disease, Hepatitis C, HIV, sarcoidosis, amyloidosis, active TBC, graft versus host disease * Past head and neck radiation treatment * Subjects who are impaired, incapacitated, or incapable of completing cohort-related assessments such as a questionnaire * Serious comorbidity or laboratory abnormalities that, in the opinion of the investigator, unacceptably increases the burden of participation in the study * Severe psychiatric or physical illness * Following an extreme diet (e.g. parenteral nutrition or macrobiotic diet) * Use of antibiotics within the previous two months * Use of immunosuppressive medication * Gastro-enteritis when taking the stool sample
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mouth wash, buccal swab and stool samples Microbiome data: • Relative abundance; quantitative measure of the number of micro-organisms, operational taxonomic units (OTUs), or sequences detected in a sample, in relation to all other micro-organisms in the same sample. • Richness; the number of unique organisms detected in one sample. • Diversity; (measured with the species richness and abundance) within (alpha-diversity) and between (beta-diversity) samples. • Distance; a measure of the differences between samples (conducting principal component analysis) based on beta-diversity. • UniFrac phylogenetic distance; the phylogenetic distance between sets of taxa in a phylogenetic tree as the fraction of the branch length of the tree that leads to descendants from either one environment or the other, but not both. Laboratory parameters: • Levels of IgA and IgM in mouth wash and stool samples | — |
Secondary
| Measure | Time frame |
|---|---|
| - Dutch Periodontal Screening Index score (DPSI score) - Food consumption - Data on perinatal period (birth weight and length, type of delivery, breastfeeding y/n) (6 questions) - Xerostomia Inventory (11 questions) - WHO Oral Health questionnaire for adults (16 questions) | — |
Countries
The Netherlands
Outcome results
None listed