NCT04853212招募中不适用
The Role of Dysbiosis of Intestinal Microbiota in the Development of Spondyloarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Isolation and characterization of R. gnavus
研究概览
简要总结
The primary objective of this case-control study aims to explore the role of bacterium Ruminococcus gnavus (R. gnavus) with intestinal biopsy and faecal sampling in the initiation and the development of spondyloarthritis (SPA) in comparison with health control subjets (patients without chronic disease but have indication to digestive endoscopy).
详细描述
As secondary objectives, the study aims:
- to research the abundance of bacterial strain of R. gnavus in mucosal sampling by biopsy;
- to study the interaction between R. gnavus bacterium and mucus from histological sampling;
- to correlate the expression of genes of intestinal mucus with the variations of identified microbiota of mucus biopsy;
- to study the interaction between bacteria and intestinal epithelial cells during culture;
- to demonstrate perturbations of the immune responses by dysbiosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Patients with SPA:
- •Patients ⩾ 18 years;
- •Diagnosed as spondyloarthritis (SpA) according ASAS classification;
- •Affiliated to a social security scheme;
- •Have signed the written informed consent form.
- •Control subjects:
- •Subjects ⩾ 18 years;
- •Subjects free of SPA and planned for a digestive endoscopy for another indication such as to explore the risk of colorectal cancer in family member;
- •Affiliated to a social security scheme;
- •Have signed the written informed consent form.
排除标准
- •Subjects unable to understand the proposed study and/or sign a informed consent form;
- •Pregnant women or breast feeding women;
- •Subjects under guardianship or curatorship;
- •Have taken antibiotic 1 month prior to inclusion;
- •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.
结局指标
主要结局
Isolation and characterization of R. gnavus
时间窗: At the end of study, up to 2 years
Isolation and characterization of R. gnavus bacterium from intestinal biopsy.
Bacteria analysis
时间窗: At the end of study, up to 2 years
Analysis of repartition of R. gnavus bacterium in each group and the comparison between 2 groups.
次要结局
- RNA sequencing analysis of biopsy(At the end of study, up to 2 years)
- Mucin-degradation of Ruminococcus gnavus(At the end of study, up to 2 years)
- Interaction between bacteria and intestinal epithelial cells(At the end of study, up to 2 years)
- Dysbiosis-induced immune perturbations(At the end of study, up to 2 years)
- Bacterial strain's abundance(At the end of study, up to 2 years)
研究者
研究点 (2)
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