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Neurotrophins Implications in Primary Sjögren Syndrome

Neurotrophins Implications in Primary Sjögren Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01081184
Acronym
Neuro-SGSp
Enrollment
40
Registered
2010-03-05
Start date
2010-03-31
Completion date
2012-08-31
Last updated
2013-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjögren Syndrome

Keywords

primary Sjögren syndrome, neurotrophins, B cell, sicca syndrome, T cell

Brief summary

Neurotrophins (NTs) constitute a family of growth factors, which regulated differentiation, proliferation, and survival of both neuronal cells and astrocytes. In recent years, several studies have provided evidences that the cellular effects of NGF Nerve Growth Factor , BDNF Brain-Derived Neurotrophic Factor and NT-3 are not limited to the nervous system. Indeed, neurotrophins and their receptors are widely expressed on non neuronal cells. Data concerning the implication of NTs and their receptors in the immune system maturation and in the regulation of normal and pathological immune responses are numerous and suggest the existence of a specific neuro-immunomodulation through these neuropeptides. The aim of the study is to compare Sjögren's syndrome systemic activity to seric, lymphocytic and conjunctival levels of NTs (i.e NGF, BDNF and NT-3). A preliminary study has previously pointed out the link between high BDNF seric levels and Sjögren's systemic activity. The increased levels of BDNF were correlated to T cell activation. A similar correlation between high NGF level and hypergammaglobulinemia was also pointed out.

Detailed description

2 supplementary blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up. Salivary sicca syndrome will be evaluated with un-stimulated salivary flow rate. Saliva fluid will be collected from NTs levels determination (ELISA). Ocular sicca syndrome will be evaluated by Schirmer tests and Lissaline green test. A conjunctival cytological impression will be done in order to determine NTs conjunctival production by flow cytometry.

Interventions

BIOLOGICALblood sample

blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Arm : primary Sjögren syndrome: * All patients must fulfill the revised criteria for primary Sjögren syndrome. * Age of entry into the study ≥ 18 yrs. * Affiliated or profit patient of a social security system. * Informed consent signed up. Arm : healthy volunteers: * All patient free of autoimmune disease. * Age of entry into the study ≥ 18 yrs. * Affiliated or profit patient of a social security system. * Informed consent signed up.

Exclusion criteria

* Patient with psychiatric disorders not related with antiphospholipid syndrome and / or cerebral complication of SGSp. * Addictive behaviors (alcoholism, cocaine or opioid abuse). * Patient with anti-depressive drugs. * Patient with concurrent malignancy * Pregnancy * Patients under measure of maintenance of justice. * Patients unable to understand or to participate to the study. * Child and major patients making the object of a measure of lawful protection. * Patients deprived of freedom.

Design outcomes

Primary

MeasureTime frameDescription
Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3)1 day2 supplementary blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up.

Secondary

MeasureTime frameDescription
Disease activity score used: ESSDAI; NGF, BDNF and NT3 levels in sera; pSS immunological profile; intensity of sicca syndrome; salivary levels of NTs; conjunctival expression of NTs.1 daySalivary sicca syndrome will be evaluated with un-stimulated salivary flow rate. Saliva fluid will be collected from NTs levels determination (ELISA). Ocular sicca syndrome will be evaluated by Schirmer tests and Lissaline green test. A conjunctival cytological impression will be done in order to determine NTs conjonctival production by flow cytometry.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026