Ignite Creation Date:
2024-05-06 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03157011
Status:
COMPLETED
Last Update Posted:
2018-09-13
First Post:
2017-05-02
Brief Title:
Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GASTRO-SGS
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 Sjogrens Syndrome Patient Reported Index ESSPRI and ESSDAI EULAR Sjögrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None