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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Sjögren Syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker detection | Other | Quantification of serum markers of intestinal permeability and bacterial and fungal translocation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | Upon changing disease activity level (maximum 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Upon changing disease activity level (maximum 3 years) |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients (≥ 18 years old) with primary Sjögren's syndrome according to the AECG criteria and / or validation by an expert, subject to their agreement, followed in one of the departments participating in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Radjiv Goulabchand | CHU Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nimes | Nîmes | France |
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Plasma, blood, stool and saliva
| 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) | 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 | 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) | 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) | 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 | 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) | 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) | 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 | 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) | 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) | 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 | Upon changing disease activity level (maximum 3 years) |
| EQ-5D-5L questionnaire | score 0-100 | Baseline |
| EQ-5D-5L questionnaire | score 0-100 | Upon changing disease activity level (maximum 3 years) |
| World Health Organization Quality Of Life BREF questionnaire | score 0-100 | Baseline |
| World Health Organization Quality Of Life BREF questionnaire | score 0-100 | Upon changing disease activity level (maximum 3 years) |
| Hospital Anxiety and Depression Scale | score 0-42 | Baseline |
| Hospital Anxiety and Depression Scale | score 0-42 | Upon changing disease activity level (maximum 3 years) |
| Multidimensional Fatigue Inventory | score 4-20 | Baseline |
| Multidimensional Fatigue Inventory | score 4-20 | Upon changing disease activity level (maximum 3 years) |
| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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