Sjogren's SyndromeIMISSNCT04462601
Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity
An observational study of Sjogren's Syndrome, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Biomarker detection
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2020to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- The patient must be a member or beneficiary of a health insurance plan
- Patients with primary Sjögren's syndrome according to the AECG criteria
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Biomarker detection
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker detectionOther
Quantification of serum markers of intestinal permeability and bacterial and fungal translocation
| Study group | Role | What they receive |
|---|---|---|
| Patients with Sjögren Syndrome | Not described Receives: Other: Biomarker detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
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)
Measured: Upon changing disease activity level (maximum 3 years)
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)
Measured: 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)
pg/ml, measured by ELISA
Measured: 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
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)
Measured: Upon changing disease activity level (maximum 3 years)
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)
Measured: Upon changing disease activity level (maximum 3 years)
Difference in soluble CD14 levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
ng/ml, measured by ELISA
Measured: Upon changing disease activity level (maximum 3 years)
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)
Measured: Upon changing disease activity level (maximum 3 years)
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)
Measured: Upon changing disease activity level (maximum 3 years)
Difference in fungal 18s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
PCR and sequencing
Measured: Upon changing disease activity level (maximum 3 years)
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)
Measured: Upon changing disease activity level (maximum 3 years)
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)
Measured: Upon changing disease activity level (maximum 3 years)
Difference in bacterial 16s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
PCR and sequencing
Measured: Upon changing disease activity level (maximum 3 years)
EQ-5D-5L questionnaire
score 0-100
Measured: Baseline
EQ-5D-5L questionnaire
score 0-100
Measured: Upon changing disease activity level (maximum 3 years)
World Health Organization Quality Of Life BREF questionnaire
score 0-100
Measured: Baseline
World Health Organization Quality Of Life BREF questionnaire
score 0-100
Measured: Upon changing disease activity level (maximum 3 years)
Hospital Anxiety and Depression Scale
score 0-42
Measured: Baseline
Hospital Anxiety and Depression Scale
score 0-42
Measured: Upon changing disease activity level (maximum 3 years)
Multidimensional Fatigue Inventory
score 4-20
Measured: Baseline
Multidimensional Fatigue Inventory
score 4-20
Measured: Upon changing disease activity level (maximum 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start13 Nov 2020
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radjiv Goulabchand, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462601
- Sponsor's protocol ID
- NIMAO/2019-01/RG-01
- Acronym
- IMISS
- Status last verified
- Nov 2025
- First submitted
- 3 Jul 2020
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity
- ClinicalTrials.gov ID
- NCT04462601
- Acronym / sponsor ID
- IMISS / NIMAO/2019-01/RG-01
- Conditions
- Sjogren's Syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Sjögren Syndrome | – | Other: Biomarker detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- The patient must be a member or beneficiary of a health insurance plan
- Patients with primary Sjögren's syndrome according to the AECG criteria
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker detectionQuantification of serum markers of intestinal permeability and bacterial and fungal translocation | Other | Patients with Sjögren Syndrome |
Primary outcome
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)
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)
20 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
EQ-5D-5L questionnaire
Time frame: Baseline
EQ-5D-5L questionnaire
Time frame: Upon changing disease activity level (maximum 3 years)
World Health Organization Quality Of Life BREF questionnaire
Time frame: Baseline
World Health Organization Quality Of Life BREF questionnaire
Time frame: Upon changing disease activity level (maximum 3 years)
Hospital Anxiety and Depression Scale
Time frame: Baseline
Hospital Anxiety and Depression Scale
Time frame: Upon changing disease activity level (maximum 3 years)
Multidimensional Fatigue Inventory
Time frame: Baseline
Multidimensional Fatigue Inventory
Time frame: Upon changing disease activity level (maximum 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radjiv Goulabchand principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.