NCT03376230终止不适用
Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2010年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients.
研究概览
简要总结
Inflammatory Bowel Diseases (IBD) including Crohn's disease and ulcerative colitis are multifactorial diseases leading to chronic inflammation of intestinal mucosa. Their etiology is still unknown. Recently, major advances in the understanding of their pathophysiology have allowed to define them as heterogenic polygenic diseases, occurring in genetically susceptible patients. However, the whole genetic susceptibility does not explain the development of IBD and several data argue in favor of the involvement of environmental factors, which remain to be identified.
The aims of this clinical trial are:
- As main objective: To determine the effects of environmental pollutants on intestinal homeostasis and particularly on inflammatory process and endoplasmic reticulum stress.
- As secondary objective, to assess in human the genetic susceptibility of intestinal mucosa to environmental chemical compounds (I.e. xenobiotics), its interindividual variability, and its potential involvement in the pathogenesis of IBD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are at least 18 years old
- •Has Crohn's disease or ulcerative colitis, diagnosed, confirmed by radiological and / or endoscopic examination within 4 years or "Control" patient not suffering from inflammatory bowel disease (patient with abdominal pain and / or persistent diarrhea, or patient requiring coloscopy for cancer of the digestive tract diagnosis)
- •Patients requiring coloscopy as part of their medical follow-up
- •Social insured.
排除标准
- •Pregnant women
- •Breastfeeding women
- •People in emergency
- •Persons unable to understand, read and / or sign informed consent
- •Patients who recently had an intercurrent episode (eg recent diarrhea ...)
- •Persons deprived of their liberty
- •Persons protected by a legal protection status
结局指标
主要结局
Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients.
时间窗: Baseline
次要结局
- Comparison of expression pattern of genes involved in xenobiotics detoxification in intestinal mucosa in between the 3 groups of patients.(Baseline)
研究者
研究点 (1)
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