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

Not Applicable

Completed

• Conditions: Digestive System Abnormalities; Sjogren's Syndrome
• Interventions: Other: Global symptom score (GSS) questionary

• Registration Number: NCT03157011
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Study Start: 2017-07-17
• Primary Completion: 2018-06-28
• Study Completion: 2018-06-28
• Status Verified: 2018-07
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital, Limoges; 🇫🇷 Limoges, France