Gougerot-Sjögren syndrome or Sjögren syndrome is a chronic autoimmune disease belonging to connectivitis, the classic triad of symptoms being the association of a sicca syndrome (generally predominant in the mouth and / or ocular, but also present at the cutaneous, vaginal or tracheal level), diffuse arthromyalgia and marked fatigue. The study investigators hypothesize that changes in the gut microbiota, by modulating gut permeability and thereby promoting microbial translocation, would have immunomodulatory effects that could be correlated to changes in the activity of Gougerot-Sjögren disease.
Study Type
OBSERVATIONAL
Enrollment
50
Quantification of serum markers of intestinal permeability and bacterial and fungal translocation
CHU de Nimes
Nîmes, France
Difference in Intestinal Fatty Acid Binding Protein (I-FABP) levels from baseline in patients passing to a different level of disease activity
ng/ml measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in zonulin-1 levels from baseline in patients passing to a different level of disease activity
ng/ml measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in LPS-binding Protein levels from baseline in patients passing to a different level of disease activity
pg/ml, measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in LPS-binding Protein levels from baseline in patients reporting an improvement in disease activity
pg/ml, measured by ELISA; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in LPS-binding Protein levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
pg/ml, measured by ELISA
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in soluble CD14 levels from baseline in patients passing to a different level of disease activity
ng/ml, measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in soluble CD14 levels from baseline in patients reporting an improvement in disease activity
ng/ml, measured by ELISA; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in soluble CD14 levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
ng/ml, measured by ELISA
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in fungal 18s RNA levels from baseline in patients passing to a different level of disease activity
PCR and sequencing; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in fungal 18s RNA levels from baseline in patients reporting an improvement in disease activity
PCR and sequencing; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in fungal 18s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
PCR and sequencing
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in bacterial 16s RNA levels from baseline in patients passing to a different level of disease activity
PCR and sequencing; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in bacterial 16s RNA levels from baseline in patients reporting an improvement in disease activity
PCR and sequencing; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)
Time frame: Upon changing disease activity level (maximum 3 years)
Difference in bacterial 16s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
PCR and sequencing
Time frame: Upon changing disease activity level (maximum 3 years)
EQ-5D-5L questionnaire
score 0-100
Time frame: Baseline
EQ-5D-5L questionnaire
score 0-100
Time frame: Upon changing disease activity level (maximum 3 years)
World Health Organization Quality Of Life BREF questionnaire
score 0-100
Time frame: Baseline
World Health Organization Quality Of Life BREF questionnaire
score 0-100
Time frame: Upon changing disease activity level (maximum 3 years)
Hospital Anxiety and Depression Scale
score 0-42
Time frame: Baseline
Hospital Anxiety and Depression Scale
score 0-42
Time frame: Upon changing disease activity level (maximum 3 years)
Multidimensional Fatigue Inventory
score 4-20
Time frame: Baseline
Multidimensional Fatigue Inventory
score 4-20
Time frame: Upon changing disease activity level (maximum 3 years)
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