IMISS: Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with Sjögren Syndrome
|
Other: Biomarker detection
Quantification of serum markers of intestinal permeability and bacterial and fungal translocation
|
Outcome Measures
Primary Outcome Measures
- Difference in Intestinal Fatty Acid Binding Protein (I-FABP) levels from baseline in patients passing to a different level of disease activity [Upon changing disease activity level (maximum 2 years)]
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)
- Difference in zonulin-1 levels from baseline in patients passing to a different level of disease activity [Upon changing disease activity level (maximum 2 years)]
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)
Secondary Outcome Measures
- Difference in LPS-binding Protein levels from baseline in patients passing to a different level of disease activity [Upon changing disease activity level (maximum 2 years)]
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)
- Difference in LPS-binding Protein levels from baseline in patients reporting an improvement in disease activity [Upon changing disease activity level (maximum 2 years)]
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)
- Difference in LPS-binding Protein levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate) [Upon changing disease activity level (maximum 2 years)]
pg/ml, measured by ELISA
- Difference in soluble CD14 levels from baseline in patients passing to a different level of disease activity [Upon changing disease activity level (maximum 2 years)]
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)
- Difference in soluble CD14 levels from baseline in patients reporting an improvement in disease activity [Upon changing disease activity level (maximum 2 years)]
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)
- Difference in soluble CD14 levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate) [Upon changing disease activity level (maximum 2 years)]
ng/ml, measured by ELISA
- Difference in fungal 18s RNA levels from baseline in patients passing to a different level of disease activity [Upon changing disease activity level (maximum 2 years)]
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)
- Difference in fungal 18s RNA levels from baseline in patients reporting an improvement in disease activity [Upon changing disease activity level (maximum 2 years)]
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)
- Difference in fungal 18s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate) [Upon changing disease activity level (maximum 2 years)]
PCR and sequencing
- Difference in bacterial 16s RNA levels from baseline in patients passing to a different level of disease activity [Upon changing disease activity level (maximum 2 years)]
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)
- Difference in bacterial 16s RNA levels from baseline in patients reporting an improvement in disease activity [Upon changing disease activity level (maximum 2 years)]
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)
- Difference in bacterial 16s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate) [Upon changing disease activity level (maximum 2 years)]
PCR and sequencing
- EQ-5D-5L questionnaire [Baseline]
score 0-100
- EQ-5D-5L questionnaire [Upon changing disease activity level (maximum 2 years)]
score 0-100
- World Health Organization Quality Of Life BREF questionnaire [Baseline]
score 0-100
- World Health Organization Quality Of Life BREF questionnaire [Upon changing disease activity level (maximum 2 years)]
score 0-100
- Hospital Anxiety and Depression Scale [Baseline]
score 0-42
- Hospital Anxiety and Depression Scale [Upon changing disease activity level (maximum 2 years)]
score 0-42
- Multidimensional Fatigue Inventory [Baseline]
score 4-20
- Multidimensional Fatigue Inventory [Upon changing disease activity level (maximum 2 years)]
score 4-20
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nimes | Nîmes | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Radjiv Goulabchand, CHU Nimes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIMAO/2019-01/RG-01