Digestive System Abnormalities, Sjogren's Syndrome
Conditions
Keywords
Primary Sjögren syndrome - Digestive symptoms
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.
Interventions
OTHERGlobal symptom score (GSS) questionary
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.
Sponsors
University Hospital, Limoges
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Global symptom score (GSS) questionary . This questionnaire has the advantage of grading the severity of These digestive symptoms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of functional digestive symptoms during SGSp | 19 months (End of study) | Measure the prevalence of functional digestive symptoms during SGSp globally and as a function of the duration of the disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of each GSS symptom | 19 months (End of study) | Measure the prevalence of each GSS symptom and its severity during the pSGS, globally and depending on the duration of disease |
| Prevalence of stomach digestive symptoms | 19 months (End of study) | Measure the prevalence of each GSS symptom and its severity during the pSGS, globally and depending on the duration of disease |
| Association between the presence of digestive disorders and SGSp activity | 19 months (End of study) | 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 |
| Association between the presence of digestive symptoms, the existence of a sicca syndrome at the time of screening | 19 months (End of study) | 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 |
| Digestive disorders | 19 months (End of study) | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORANNE-LAURE FAUCHAIS, PH
University Hospital, Limoges
Outcome results
None listed