Clinical trial NCT04462601: Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity
Official title: Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sjogren's Syndrome
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: Difference in Intestinal Fatty Acid Binding Protein (I-FABP) levels from baseline in patients passing to a different level of disease activity
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in zonulin-1 levels from baseline in patients passing to a different level of disease activity
timeFrame: Upon changing disease activity level (maximum 3 years)
Secondary outcomes:
measure: Difference in LPS-binding Protein levels from baseline in patients passing to a different level of disease activity
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in LPS-binding Protein levels from baseline in patients reporting an improvement in disease activity
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in LPS-binding Protein levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in soluble CD14 levels from baseline in patients passing to a different level of disease activity
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in soluble CD14 levels from baseline in patients reporting an improvement in disease activity
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in soluble CD14 levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in fungal 18s RNA levels from baseline in patients passing to a different level of disease activity
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in fungal 18s RNA levels from baseline in patients reporting an improvement in disease activity
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in fungal 18s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in bacterial 16s RNA levels from baseline in patients passing to a different level of disease activity
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in bacterial 16s RNA levels from baseline in patients reporting an improvement in disease activity
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Difference in bacterial 16s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: EQ-5D-5L questionnaire
timeFrame: Baseline
measure: EQ-5D-5L questionnaire
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: World Health Organization Quality Of Life BREF questionnaire
timeFrame: Baseline
measure: World Health Organization Quality Of Life BREF questionnaire
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Upon changing disease activity level (maximum 3 years)
measure: Multidimensional Fatigue Inventory
timeFrame: Baseline
measure: Multidimensional Fatigue Inventory
timeFrame: Upon changing disease activity level (maximum 3 years)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Radjiv Goulabchand
role: PRINCIPAL_INVESTIGATOR
References: