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Involvement of Immune Cells Derived From the Intestine in Sjogren's Syndrome (SINGOU)

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ClinicalTrials.gov Identifier: NCT03841318
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
The study aims at defining the role of immune cells derived from the intestine in the pathogenesis of Sjogren's disease. This research might open new therapeutic approaches for the treatment of autoimmune diseases.

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Biological: blood sample Biological: biopsy of the labial salivary gland Not Applicable

Detailed Description:

Autoimmune diseases are characterized by a loss of tolerance of the immune system for self-antigens. One of the feature of autoimmune diseases is the infiltration of lymphoid cells in the tissues damaged by the disease (i.e. kidney in systemic lupus erythematous or brain in multiple sclerosis). However, the origins and properties of the immune cells infiltrating these target tissues are largely unknown.

Studies in mouse models have shown that the composition of the gut microbiota can modify the susceptibility to autoimmune diseases. These studies demonstrated that the microbiota composition can alter the pathogenic properties of T cells in the gut but also in the target tissues. For instance, in the experimental autoimmune encephalomyelitis model, the composition of the gut microbiota has been shown to modulate the susceptibility to the disease and the properties of the pathogenic CD4 T cells in the gut but also in the central nervous system. In human an alteration in the composition of the gut microbiota is observed in numerous autoimmune diseases, including Sjogren's syndrome, suggesting that perturbation of the gut microbiota might be linked to the pathogenicity of immune cells in the target organs. However, the mechanisms by which the microbiota impacts the pathogenicity of immune cells in the target organs is unknown. It is proposed that gut immune cells directly exposed to the microbiota compounds could migrate to the target organs and participate to the buildup of tissue damages. This hypothesis is supported by studies in mouse models showing the migration of gut CD4 T cells in the inflamed kidney (glomerulonephritis model) or in the systemic lymphoid organs (rheumatoid arthritis model). The preliminary data support this hypothesis as the investigators have shown that gut-derived CD4 T cells display pathogenic properties in human autoimmune diseases. To determine whether and how the gut-derived immune cells are involved in the pathogenesis of autoimmune disease, the investigators propose to study the origin and properties of immune cells infiltrated in target tissues in autoimmune diseases.

Sjogren's syndrome is a systemic autoimmune disease in which exocrine gland in particular lacrimal and salivary glands are affected. One of the hallmark of the disease is the infiltration of lymphoid cells in the exocrine glands of the patients. Indeed, the presence of lymphoid infiltrate in the minor labial salivary gland of the patients is one of the most important diagnostic tool for Sjogren's syndrome. The investigation of lymphoid infiltrates requires to perform a biopsy of the labial salivary gland. The investigators propose here to take advantage of this minimally invasive procedure to study the properties of the lymphoid cells present in the minor salivary glands of Sjogren's patients.

The study will recruit 200 patients followed in Bordeaux University Hospital in which a salivary gland biopsy is performed for a clinical suspicion of Sjogren's syndrome. Blood and a biopsy of the minor salivary gland of the lip will be collected during a scheduled visit to study the properties of infiltrated immune cells. Clinical and biological disease activity, treatment and outcomes will be studied in correlation with the properties of infiltrated immune cells. No extra visit will be needed and the biopsy of the minor salivary gland of the lip and the blood samples will be collected at the same times as those collected for clinical purposes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Involvement of Immune Cells Derived From the Intestine in Sjogren's Syndrome
Actual Study Start Date : August 3, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sjogren's Syndrome Biological: blood sample
36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Biological: biopsy of the labial salivary gland
Part of the biopsy of the labial salivary gland




Primary Outcome Measures :
  1. Quantification of the immune cells infiltrated in the minor salivary glands of Sjogren's patients. [ Time Frame: At baseline (Day 0) ]

Secondary Outcome Measures :
  1. Quantification of disease activity scores for Sjogren's patients evalued by EULAR Sjögren Syndrome Disease Activity Index [ Time Frame: At baseline (Day 0) ]
    EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) : between 0 and 123, in which higher values indicate higher severity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspicion of Sjogren's syndrome based on 2016 American College of Rheumatology (ACR) criteria;
  • Age ≥ 18 years
  • Being affiliated to health insurance
  • Willing to participate

Exclusion Criteria:

  • Pregnant or breastfeeding women,
  • Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841318


Contacts
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Contact: Pierre DUFFAU, Prof (0)5 56 79 58 28 ext +33 pierre.duffau@chu-bordeaux.fr
Contact: Nathalie SCHMITT, PhD (0)7 87 99 14 70 ext +33 nathalie.schmitt@u-bordeaux.fr

Locations
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France
CHU de Bordeaux - Service de médecine interne Recruiting
Bordeaux, France
Contact: Pierre DUFFAU, Prof    (0)5 56 79 58 28 ext +33    pierre.duffau@chu-bordeaux.fr   
Contact: Nathalie SCHMITT, PhD    (0)7 87 99 14 70 ext +33    nathalie.schmitt@u-bordeaux.fr   
Principal Investigator: Pierre DUFFAU, Prof         
Sub-Investigator: Estibaliz LAZARO, Prof         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Pierre DUFFAU, Prof CHU - Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03841318    
Other Study ID Numbers: CHUBX 2018/53
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
lymphoid cells
gut-derived lymphocytes
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases