Understanding the Role of the Salivary Microbiota and Microbiota Associated to Mucosa in Behçet's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Oral microbiota
研究概览
简要总结
Behçet's disease (BD) is a systemic vasculitis that affects, especially, young people.
Although its etiology remains unexplained, data suggest that the inflammatory response during BD results from a disruption of the homeostasis of innate and adaptive immune responses in genetically predisposed people. The microbiota could play a triggering role in BD, in particular the salivary and dental plaque microbiota. The aim of the Behçetbiot study is therefore to establish microbial profiles of dental plaque, pathological (on the mouth ulcer) and non-pathological mucous membrane, salivary and digestive and to compare them with control subjects not suffering from BD, related to the first degree, of the same socio-cultural level and to determine whether dysbiosis is correlated with a local and systemic pro-inflammatory response, by measuring salivary level of pro-inflammatory cytokines and blood level of CRP, fibrinogen, orosomucoïd and haptoglobin, and to compare them with controls.
详细描述
All patients and their controls are sampled for stool, saliva, dantal plaque, oral mucosa, genital mucosa and blood during an annual follow-up visit or if they are hospitalised.
Plaque, oral mucosa, genital mucosa salivary and blood will be collected during an annual follow-up visit.
For stool samples, the collection material will be provided to the patient and they will be able to take the sample at home and bring it to the clinic, or send them via a carrier within 3 days.
All the samples related to the study will be taken in the internal medicine in Clermont-Ferrand (France) or Pitie Salpêtrière, department of internal medecine, Paris,France or ophthalmology departments in Clermont-Ferrand.
All sample will be stocked in biological center in Clermont-Ferrand before analyze.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the International criteria for the classification of Behçet's disease, revised in 2013)
- •Patient who had developed the disease in the 5 years preceding the study.
排除标准
- •Pregnant or breastfeeding women, or women who may be pregnant or breastfeeding.
- •Subject placed under judicial protection.
- •Patient had received antibiotic or probiotic or symbiotic therapy in the 6 weeks preceding inclusion
结局指标
主要结局
Oral microbiota
时间窗: Day 0
Establish microbial profiles (quantitative and qualitative via analysis of bacterial DNA sequences encoding 16S rRNA) of dental plaque, pathological (on the aphta) and non-pathological oral mucosa and and salivary and compared them to control without Behçet's disease matched for sex, diet and socio-cultural level.
次要结局
- Intestinal microbiota(Day 0)
- Short fatty acid(Day 0)
- Pro-inflammatory cytokines(Day 0)
- genital microbiota(Day 0)