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

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 Overview

• Status: Active, not recruiting
• Conditions: Sjogren's Syndrome
• Intervention / Treatment: Other: Biomarker detection

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Sjögren Syndrome	Other: Biomarker detection; Quantification of serum markers of intestinal permeability and bacterial and fungal translocation

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Radjiv Goulabchand, CHU Nimes

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome
• Other Study ID Numbers: NIMAO/2019-01/RG-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No