Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Prevalence of functional digestive symptoms during SGSp
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Global symptom score (GSS) questionary
systematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary.
干预措施: Global symptom score (GSS) questionary (Other)
结局指标
主要结局
Prevalence of functional digestive symptoms during SGSp
时间窗: 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
次要结局
- Prevalence of each GSS symptom(19 months (End of study))
- Prevalence of stomach digestive symptoms(19 months (End of study))
- Association between the presence of digestive disorders and SGSp activity(19 months (End of study))
- Association between the presence of digestive symptoms, the existence of a sicca syndrome at the time of screening(19 months (End of study))
- Digestive disorders(19 months (End of study))