Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome

Study Overview
=================
Brief Summary
-----------------
the investigators propose to carry out a prospective study consisting of a systematic research of digestive symptoms in patients with SGSp with the validated Global symptom score (GSS) questionnaire, which allowed to grades severity of 10 digestive symptoms (absent, mild, moderate, or severe), asthenia and fever.

Detailed Description
-----------------
Primary Sjögren syndrome (SGSp) is an autoimmune disease defined by the association of sicca syndrome in the absence of other connective tissues (ie rheumatoid arthritis, systemic lupus erythematosus, scleroderma, dermatopolymyositis). SGSp is complicated by several visceral involvements (pulmonary, renal, neurological, systemic vasculitis ...) and by a chronic alteration of the quality of life related to asthenia, chronic pain and sicca syndrome. Two European-validated scales are currently used in daily clinical practice to assess these two facets of the disease, respectively EUSSAR Sjogren's Syndrome Patient Reported Index (ESSPRI) and ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index). Neither of these two scores evaluate the digestive impairment. Indeed, digestive complaints have been evaluated in a few studies, with a prevalence of 30 to 65%. The precise etiopathogeny of such digestive involvements remains unknown.

Official Title
-----------------
Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome

Conditions
-----------------
Sjogren's Syndrome, Digestive System Abnormalities

Intervention / Treatment
-----------------
* Other: Global symptom score (GSS) questionary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with SGSp according to revised American-European criteria Patients 18 years of age or older Patients affiliated to the French social security care system. Exclusion Criteria: 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. Concomitant interventional clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Global symptom score (GSS) questionary . This questionnaire has the advantage of grading the severity of These digestive symptoms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Global symptom score (GSS) questionary<br>systematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary. | Other: Global symptom score (GSS) questionary<br>* systematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary, which allowed to grades severity of 10 digestive symptoms (absent, mild, moderate, or severe), asthenia and fever.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of functional digestive symptoms during SGSp | Measure the prevalence of functional digestive symptoms during SGSp globally and as a function of the duration of the disease | 19 months (End of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of each GSS symptom | Measure the prevalence of each GSS symptom and its severity during the pSGS, globally and depending on the duration of disease | 19 months (End of study) | 
| Prevalence of stomach digestive symptoms | Measure the prevalence of each GSS symptom and its severity during the pSGS, globally and depending on the duration of disease | 19 months (End of study) | 
| Association between the presence of digestive disorders and SGSp activity | Determine the possible association between the presence of digestive disorders (each symptom) and SGSp activity, painfulness experienced by the patient, anti-SSA antibody, and / or SSB | 19 months (End of study) | 
| Association between the presence of digestive symptoms, the existence of a sicca syndrome at the time of screening | Determine the possible association between the presence of digestive symptoms, the existence of a sicca syndrome at the time of screening, neurological involvement, pulmonary involvement, parotiditis, depressive disorders, fibromyalgia, hypergammaglobulinemia | 19 months (End of study) | 
| Digestive disorders | Describe the digestive disorders discovered by the digestive explorations generated by the existence of digestive symptoms, in accordance with the usual rules of good practice | 19 months (End of study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Sjögren syndrome - Digestive symptoms