NCT04462601Active, not recruiting
Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 3 Jul 2020
- Start date
- 13 Nov 2020
- Primary completion date
- Oct 2028
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Diseases
- Sjögren's disease
- NCT number
- NCT04462601
What you commit to
- Study type: Observational
- Planned participants: 50
- From 13 Nov 2020 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The subject is participating in a category I interventional study, or is in a period of exclusion determined by a previous study
Other illness
- Patients with secondary Sjögren's syndrome
Other
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Pregnant, parturient or breastfeeding patients
Who the study is looking for
- The patient must be a member or beneficiary of a health insurance plan
- Patients with primary Sjögren's syndrome according to the AECG criteria
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.