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

NCT04462601 | Active Not Recruiting

• 1 other identifier: NIMAO/2019-01/RG-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• Difference in LPS-binding Protein levels from baseline in patients passing to a different level of disease activity

  Upon changing disease activity level (maximum 3 years)

• Difference in LPS-binding Protein levels from baseline in patients reporting an improvement in disease activity

  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)

  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

  Upon changing disease activity level (maximum 3 years)

• Difference in soluble CD14 levels from baseline in patients reporting an improvement in disease activity

  Upon changing disease activity level (maximum 3 years)

Study Arms (1)

Patients with Sjögren Syndrome

Other: Biomarker detection

Interventions

Biomarker detection OTHER

Quantification of serum markers of intestinal permeability and bacterial and fungal translocation

Patients with Sjögren Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The patient must be a member or beneficiary of a health insurance plan
• Patients with primary Sjögren's syndrome according to the AECG criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, blood, stool and saliva

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Radjiv Goulabchand

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 8, 2020
• Study Start: November 13, 2020
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1)