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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-17

Study Completion Date

2018-06-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sjogren's Syndrome Digestive System Abnormalities

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Global symptom score (GSS) questionary . This questionnaire has the advantage of grading the severity of These digestive symptoms.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Global symptom score (GSS) questionary

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

Group Type EXPERIMENTAL

Global symptom score (GSS) questionary

Intervention Type OTHER

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.

Interventions

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Global 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No