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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University Hospital, Limoges

Current Primary Outcome: Prevalence of functional digestive symptoms during SGSp [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Prevalence of each GSS symptom [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: University Hospital, Limoges

Dates:
Date Received: May 2, 2017
Date Started: September 15, 2017
Date Completion: March 30, 2019
Last Updated: May 15, 2017
Last Verified: April 2017