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

Centre Hospitalier Universitaire de Nīmes

Status: Active, not recruiting

Conditions: Sjogren's Syndrome

Treatments: Other: Biomarker detection

Study type: Observational

Funder types: Other

Identifiers

NCT04462601

NIMAO/2019-01/RG-01

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Patients with Sjögren Syndrome

Treatment:

Other: Biomarker detection