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Active, Not Recruiting

NCT Number: NCT04462601

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomarker detection

Other

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

Primary outcomes

  1. Difference in Intestinal Fatty Acid Binding Protein (I-FABP) levels from baseline in patients passing to a different level of disease activity

    Time frame: Upon changing disease activity level (maximum 3 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)

  2. Difference in zonulin-1 levels from baseline in patients passing to a different level of disease activity

    Time frame: Upon changing disease activity level (maximum 3 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 outcomes

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

    Time frame: Upon changing disease activity level (maximum 3 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)

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

    Time frame: Upon changing disease activity level (maximum 3 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)

  3. Difference in LPS-binding Protein levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)

    Time frame: Upon changing disease activity level (maximum 3 years)

    pg/ml, measured by ELISA

  4. Difference in soluble CD14 levels from baseline in patients passing to a different level of disease activity

    Time frame: Upon changing disease activity level (maximum 3 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)

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

    Time frame: Upon changing disease activity level (maximum 3 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)

  6. Difference in soluble CD14 levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)

    Time frame: Upon changing disease activity level (maximum 3 years)

    ng/ml, measured by ELISA

  7. Difference in fungal 18s RNA levels from baseline in patients passing to a different level of disease activity

    Time frame: Upon changing disease activity level (maximum 3 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)

  8. Difference in fungal 18s RNA levels from baseline in patients reporting an improvement in disease activity

    Time frame: Upon changing disease activity level (maximum 3 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)

  9. Difference in fungal 18s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)

    Time frame: Upon changing disease activity level (maximum 3 years)

    PCR and sequencing

  10. Difference in bacterial 16s RNA levels from baseline in patients passing to a different level of disease activity

    Time frame: Upon changing disease activity level (maximum 3 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)

  11. Difference in bacterial 16s RNA levels from baseline in patients reporting an improvement in disease activity

    Time frame: Upon changing disease activity level (maximum 3 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)

  12. Difference in bacterial 16s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)

    Time frame: Upon changing disease activity level (maximum 3 years)

    PCR and sequencing

  13. EQ-5D-5L questionnaire

    Time frame: Baseline

    score 0-100

  14. EQ-5D-5L questionnaire

    Time frame: Upon changing disease activity level (maximum 3 years)

    score 0-100

  15. World Health Organization Quality Of Life BREF questionnaire

    Time frame: Baseline

    score 0-100

  16. World Health Organization Quality Of Life BREF questionnaire

    Time frame: Upon changing disease activity level (maximum 3 years)

    score 0-100

  17. Hospital Anxiety and Depression Scale

    Time frame: Baseline

    score 0-42

  18. Hospital Anxiety and Depression Scale

    Time frame: Upon changing disease activity level (maximum 3 years)

    score 0-42

  19. Multidimensional Fatigue Inventory

    Time frame: Baseline

    score 4-20

  20. Multidimensional Fatigue Inventory

    Time frame: Upon changing disease activity level (maximum 3 years)

    score 4-20

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: IMISS

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jul 8, 2020
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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