Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- The proportion of filamentous bacteria in the intestinal microbiota
研究概览
简要总结
The main objective of this study is to compare the intestinal microbiota in newly diagnosed rheumatoid arthritis (RA) with that from individuals without RA.
The first analysis will compare the proportion of filamentous bacteria in the intestinal microbiota between the two groups.
详细描述
The secondary objectives of this study are :
- A. To compare between the two groups :
- a. The proportion of Proteus mirabilis in the intestinal microbiota;
- b . The proportion of species producing peptidyl arginine deaminase (PAD ) in the intestinal microbiota;
- c . The number of species found in the intestinal microbiota.
- B. To evaluate bacterial translocation (from the digestive tract) in newly diagnosed RA patients with and healthy volunteers without RA. (Bacterial translocation is a phenomenon in which live bacteria or a part of bacteria (e.g. LPS teichoïc acid) cross the intestinal barrier and reach the bloodstream.).
- C. To describe the ecology of the intestinal microbiota of newly diagnosed RA patients (characterization of species found according to their respiratory metabolism, according to their bacteriological characteristics, and according to whether or not the species are found significantly more frequently in patients with RA than in individuals without RA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
RA patients
This group is composed of 25 patients with RA. The diagnosis of RA is based upon the American College of Rheumatology criteria.
- Intervention: Plasma analysis for bacterial translocation
- Intervention: Stool analysis
干预措施: Plasma analysis for bacterial translocation (Biological)
RA patients
This group is composed of 25 patients with RA. The diagnosis of RA is based upon the American College of Rheumatology criteria.
- Intervention: Plasma analysis for bacterial translocation
- Intervention: Stool analysis
干预措施: Stool analysis (Biological)
Healthy voluteers
This group is composed of 25 healthy volunteers.
- Intervention: Plasma analysis for bacterial translocation
- Intervention: Stool analysis
干预措施: Plasma analysis for bacterial translocation (Biological)
Healthy voluteers
This group is composed of 25 healthy volunteers.
- Intervention: Plasma analysis for bacterial translocation
- Intervention: Stool analysis
干预措施: Stool analysis (Biological)
结局指标
主要结局
The proportion of filamentous bacteria in the intestinal microbiota
时间窗: Baseline (day 0)
次要结局
- Presence/absence of bacterial translocation(baseline (Day 0))
- The number of species found in the intestinal microbiota(baseline (Day 0))
- Description of the ecology of intestinal microbiota(baseline (Day 0))
- The proportion of Proteus mirabilis in the intestinal microbiota(baseline (Day 0))
- The proportion of species producing peptidyl arginine desaminase (PAD) in the intestinal microbiota(baseline (Day 0))