NCT03072836Unknown不适用
Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis
Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2017年3月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Microbiota analysis
研究概览
简要总结
The FLORACROHN project aims to compare gut microbiota 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.
Fecal microbiota will be determined by 16SRNA gene 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
- Basic Science
- 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
- 否
入选标准
- •Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.
- •Patients with Crohn's disease (CT patients) diagnosed according to clinical, biological, radiological, endoscopic and / or histological criteria for 3 months. With diagnosis of spondyloarthritis exclusion on modified ASAS and / or New York criteria.
- •Patients with axial spondyloarthritis (SpA patients) diagnosed according to the modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease.
- •Patient with the capacity to give free and informed consent.
排除标准
- •Antecedent of colonic resection
- •Antibiotic or colonic colonoscopy preparation in the 8 weeks prior to stool collection (against temporary indication = collection possible before colic preparation or on the first saddle after the start of the colic preparation).
- •Ostomy at time of collection
- •extreme diet
- •unbalanced diabetes
- •Patient under guardianship, under curatorship or under safeguard of justice
研究组 & 干预措施
CD alone
Experimental
干预措施: analysing microbiota (Other)
SPA alone
Experimental
干预措施: analysing microbiota (Other)
CD + SPA
Experimental
干预措施: analysing microbiota (Other)
结局指标
主要结局
Microbiota analysis
时间窗: 6 months after last patient inclusion
16SRNA gene sequencing
次要结局
未报告次要终点
研究者
Pr Laurent PEYRIN BIROULET
Professor
Central Hospital, Nancy, France
研究点 (1)
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