Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease. Identification de Biomarqueurs de SPondylArthrite Chez Les Patients Atteints de Maladie de CROhn présents Dans le MICrobiote fécal.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Alpha and Beta diversity of Fecal fungome
研究概览
简要总结
The MICROSPA project aims to compare gut microbiota, serum cytokines, and PBMC of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA). 3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA. One group of healthy controls will be analysed as a comparator. Fecal microbiota will be determined by bacteriome, virome and fungome NGS sequencing
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Age ≥ 18 years.
- •Patients will be recruited according to 3 groups:
- •Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.
- •Patients with Crohn's disease (MC patients) with a diagnosis established according to clinical, biological criteria, radiological, endoscopic and / or histological studies for 3 months. With diagnosis of exclusion of a spondyloarthritis on criteria ASAS and / or New York modified.
- •Patients with axial spondyloarthritis (SpA patients) with a diagnosis based on modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease.
- •Patient with the ability to give free and express informed consent.
排除标准
- •History of colonic resection
- •Taking antibiotics or colon preparation for colonoscopy within 8 weeks before stool collection (Temporary contraindication = removal possible before colic or first bowel preparation after the start of colonic preparation).
- •Ostomy at the time of sampling
- •extreme diet
- •unbalanced diabetes
- •Pregnant woman
- •Patient under guardianship, under curatorship or under the protection of justice Contacts/Locations Central Contact
研究组 & 干预措施
Spondyloarthritis
Patients with established spondyloarthritis without Crohn 's disease
干预措施: Microbiota Sequencing (Other)
Crohn + spondyloarthritis
Patients suffering from both spondyloarthritis and Crohn 's disease
干预措施: Microbiota Sequencing (Other)
Healthy controls
Patients without spondyloarthritis and Crohn 's disease
干预措施: Microbiota Sequencing (Other)
Crohn's disease
Patients suffering from established Crohn 's disease without spondyloarthritis
干预措施: Microbiota Sequencing (Other)
结局指标
主要结局
Alpha and Beta diversity of Fecal fungome
时间窗: + 6 months
Alpha (number of species) and Beta diversity (distribution of species)
Alpha and Beta diversity of Fecal bacteriome
时间窗: + 6 months
Alpha (number of species) and Beta diversity (distribution of species)
Alpha and Beta diversity of Fecal virome
时间窗: + 6 months
Alpha (number of species) and Beta diversity (distribution of species)
次要结局
未报告次要终点
研究者
FERRY Marine
Doctor
Central Hospital, Nancy, France