Clinical Trials Directory

Trials / Completed

CompletedNCT03157011

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
151 (actual)
Sponsor
University Hospital, Limoges · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERGlobal symptom score (GSS) questionarysystematic 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.

Timeline

Start date
2017-07-17
Primary completion
2018-06-28
Completion
2018-06-28
First posted
2017-05-17
Last updated
2026-04-02

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03157011. Inclusion in this directory is not an endorsement.