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

Sjogren's Syndrome Clinical Trial

— IMISS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04462601
• Other study ID #: NIMAO/2019-01/RG-01
• Status: Recruiting
• Start date: November 13, 2020
• Est. completion date: May 2027

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Radjiv Goulabchand
• Phone: +33 (0)7.61.39.30.82
• Email: radjiv2001[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Intervention

Other:
• Biomarker detection
Quantification of serum markers of intestinal permeability and bacterial and fungal translocation

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	EQ-5D-5L questionnaire	score 0-100	Baseline
Secondary	EQ-5D-5L questionnaire	score 0-100	Upon changing disease activity level (maximum 3 years)
Secondary	World Health Organization Quality Of Life BREF questionnaire	score 0-100	Baseline
Secondary	World Health Organization Quality Of Life BREF questionnaire	score 0-100	Upon changing disease activity level (maximum 3 years)
Secondary	Hospital Anxiety and Depression Scale	score 0-42	Baseline
Secondary	Hospital Anxiety and Depression Scale	score 0-42	Upon changing disease activity level (maximum 3 years)
Secondary	Multidimensional Fatigue Inventory	score 4-20	Baseline
Secondary	Multidimensional Fatigue Inventory	score 4-20	Upon changing disease activity level (maximum 3 years)