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

Sjogren's Syndrome Clinical Trial

— GASTRO-SGS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157011
• Other study ID #: I16033 (GASTRO-SGS)
• Status: Completed
• Phase: N/A
• Start date: July 17, 2017
• Est. completion date: June 28, 2018

Study information

• Verified date: July 2018
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Abnormalities
• Digestive System Diseases
• Sjogren's Syndrome
• Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	University Hospital, Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)