Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference in Intestinal Fatty Acid Binding Protein (I-FABP) levels from baseline in patients passing to a different level of disease activity
研究概览
简要总结
Gougerot-Sjögren syndrome or Sjögren syndrome is a chronic autoimmune disease belonging to connectivitis, the classic triad of symptoms being the association of a sicca syndrome (generally predominant in the mouth and / or ocular, but also present at the cutaneous, vaginal or tracheal level), diffuse arthromyalgia and marked fatigue. The study investigators hypothesize that changes in the gut microbiota, by modulating gut permeability and thereby promoting microbial translocation, would have immunomodulatory effects that could be correlated to changes in the activity of Gougerot-Sjögren disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •The patient must be a member or beneficiary of a health insurance plan
- •Patients with primary Sjögren's syndrome according to the AECG criteria
排除标准
- •The subject is participating in a category I interventional study, or is in a period of exclusion determined by a previous study
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Pregnant, parturient or breastfeeding patients
- •Patients with secondary Sjögren's syndrome
结局指标
主要结局
Difference in Intestinal Fatty Acid Binding Protein (I-FABP) levels from baseline in patients passing to a different level of disease activity
时间窗: Upon changing disease activity level (maximum 3 years)
ng/ml measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
Difference in zonulin-1 levels from baseline in patients passing to a different level of disease activity
时间窗: Upon changing disease activity level (maximum 3 years)
ng/ml measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
次要结局
- Difference in LPS-binding Protein levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)(Upon changing disease activity level (maximum 3 years))
- Difference in soluble CD14 levels from baseline in patients passing to a different level of disease activity(Upon changing disease activity level (maximum 3 years))
- Difference in soluble CD14 levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)(Upon changing disease activity level (maximum 3 years))
- Difference in fungal 18s RNA levels from baseline in patients passing to a different level of disease activity(Upon changing disease activity level (maximum 3 years))
- Difference in fungal 18s RNA levels from baseline in patients reporting an improvement in disease activity(Upon changing disease activity level (maximum 3 years))
- Difference in LPS-binding Protein levels from baseline in patients passing to a different level of disease activity(Upon changing disease activity level (maximum 3 years))
- Difference in LPS-binding Protein levels from baseline in patients reporting an improvement in disease activity(Upon changing disease activity level (maximum 3 years))
- Difference in soluble CD14 levels from baseline in patients reporting an improvement in disease activity(Upon changing disease activity level (maximum 3 years))
- Difference in bacterial 16s RNA levels from baseline in patients passing to a different level of disease activity(Upon changing disease activity level (maximum 3 years))
- Difference in bacterial 16s RNA levels from baseline in patients reporting an improvement in disease activity(Upon changing disease activity level (maximum 3 years))
- Difference in fungal 18s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)(Upon changing disease activity level (maximum 3 years))
- EQ-5D-5L questionnaire(Upon changing disease activity level (maximum 3 years))
- Hospital Anxiety and Depression Scale(Upon changing disease activity level (maximum 3 years))
- Multidimensional Fatigue Inventory(Upon changing disease activity level (maximum 3 years))
- Difference in bacterial 16s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)(Upon changing disease activity level (maximum 3 years))
- World Health Organization Quality Of Life BREF questionnaire(Upon changing disease activity level (maximum 3 years))