Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome (GASTRO-SGS)

University of Limoges (UL)

Status: Completed

Conditions: Sjogren's Syndrome; Digestive System Abnormalities

Treatments: Other: Global symptom score (GSS) questionary

Study type: Interventional

Funder types: Other

Identifiers

NCT03157011

I16033 (GASTRO-SGS)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 1 patient group

Global symptom score (GSS) questionary

Experimental group

Description:

systematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary.

Treatment:

Other: Global symptom score (GSS) questionary