Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Bacteria analysis
研究概览
简要总结
The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. A comparative analysis will allow to identify the biomarkers of the specific bacteria.
详细描述
As secondary objectives, the study aims to analyse the relation between different clinical parameters such as age, gender, duration of the disease, or the nature of ongoing treatment, and the the composition of intestinal microbiota, and identify dysbiosis of bacteria, which will be specific functional signatures of intestinal microbiota in SPA and/or RA. Analyse the relation between metabolome of faecale and plasma and the composition of intestinal microbiota.
This study will be performed in the rheumatology department in Ambroise Paré hospital of APHP group in France.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Patient ⩾ 18 years;
- •Diagnosed as spondyloarthritis (SpA) according ASAS classification, or rheumatoid polyarthritis according ACR/EULAR;
- •Affiliated to a social security scheme;
- •Have signed the written informed consent form.
- •Healthy control subjects:
- •Adult women and men;
- •Subjet free of chronic pathology;
- •Affiliated to a social security scheme;
- •Have signed the written informed consent form.
排除标准
- •Patients unable to understand the proposed study and/or sign a informed consent form;
- •Pregnant women or breast feeding women;
- •Patient ⩾ 18 years;
- •Patients under guardianship or curatorship;
- •Have taken antibiotic 1 month prior to inclusion or digestive coloscopy 6 months prior inclusion;
- •Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
- •Foreign patients under french AME scheme;
- •Patients had have participated in the prior study Microbiart.
- •Healthy control subjects:
- •Subjects unable to understand the proposed study and/or sign a informed consent form;
- •Pregnant women or breast feeding women;
- •Subjects < 18 years;
- •Subjects under guardianship or curatorship;
- •Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
- •Refusal of subjects to participate to the study;
- •Foreign patients under french AME scheme;
- •Subjects had have participated in the prior study Microbiart.
研究组 & 干预措施
patients with SPA
100 SPA patients
干预措施: Faecal sampling (Biological)
patients with SPA
100 SPA patients
干预措施: Blood sampling (Biological)
Healthy subjets
200 healthy subjets in control group
干预措施: Faecal sampling (Biological)
Healthy subjets
200 healthy subjets in control group
干预措施: Blood sampling (Biological)
patients with RA
100 RA patients
干预措施: Faecal sampling (Biological)
patients with RA
100 RA patients
干预措施: Blood sampling (Biological)
结局指标
主要结局
Bacteria analysis
时间窗: At the end of study, up to 4 years
Quantitative analysis of repartition of bacteria in each group and the comparison between groups.
次要结局
- Intestinal microbiota composition(At the end of study, up to 4 years)