Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity

Study Overview
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Brief Summary
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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.

Official Title
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Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity

Conditions
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Sjogren's Syndrome

Intervention / Treatment
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* Other: Biomarker detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be a member or beneficiary of a health insurance plan Patients with primary Sjögren's syndrome according to the AECG criteria Exclusion Criteria: The subject is participating in a category I interventional study, or is in a period of exclusion determined by a previous study It is impossible to give the subject informed information The patient is under safeguard of justice or state guardianship Pregnant, parturient or breastfeeding patients Patients with secondary Sjögren's syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Sjögren Syndrome<br> | Other: Biomarker detection<br>* Quantification of serum markers of intestinal permeability and bacterial and fungal translocation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |