Clinical trial NCT03157011: Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome
Official title: Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sjogren's Syndrome
Digestive System Abnormalities
Keywords: Primary Sjögren syndrome - Digestive symptoms
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Global symptom score (GSS) questionary . This questionnaire has the advantage of grading the severity of These digestive symptoms.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of functional digestive symptoms during SGSp
timeFrame: 19 months (End of study)
Secondary outcomes:
measure: Prevalence of each GSS symptom
timeFrame: 19 months (End of study)
measure: Prevalence of stomach digestive symptoms
timeFrame: 19 months (End of study)
measure: Association between the presence of digestive disorders and SGSp activity
timeFrame: 19 months (End of study)
measure: Association between the presence of digestive symptoms, the existence of a sicca syndrome at the time of screening
timeFrame: 19 months (End of study)
measure: Digestive disorders
timeFrame: 19 months (End of study)
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital, Limoges
Study officials:
affiliation: University Hospital, Limoges
name: ANNE-LAURE FAUCHAIS, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parreau S, Jacques J, Dumonteil S, Palat S, Geyl S, Gondran G, Bezanahary H, Liozon E, Azais J, Colombie S, Jauberteau MO, Loustaud-Ratti V, Ly KH, Fauchais AL. Abdominal symptoms during Sjogren's syndrome: a pilot study. Adv Rheumatol. 2021 Jan 19;61(1):5. doi: 10.1186/s42358-021-00164-w.