Ex Vivo Experiments to Evaluate the Role of Medication on the Colon Permeability in Microscopic Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Transepithelial electircal resistance
研究概览
简要总结
Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor for MC development. However, the exact pathophysiological mechanism is unclear. It is hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due to an idiosyncratic reaction which results in a local immune response. MC patients are considered to be susceptible hosts, prone to react on administration of abovementioned drugs. In order to test this hypothesis and to generate new insights in the pathophysiology of MC, we want to perform an Ussing chamber experiment using fresh colon tissue samples. The primary objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial permeability of colon biopsy specimens of MC and non-MC patients, using the Ussing chamber system
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The indication for colonoscopy is a relapse of MC (active) / MC in remission (remission) / no MC (control)
- •Patient is not treated with NSAIDs / PPI / SSRI in week before inclusion
排除标准
- •Age below 18 years at the time of diagnosis
- •Use of anticoagulants or immunosuppressive drugs
- •Severe co-morbidities hindering an endoscopic procedure
- •A previous history of any type of chronic colitis, IBS, IBD, colon carcinoma or (partial) colectomy
- •A recent (last year) diagnosis of infectious diarrhea or radiation proctitis.
- •Use of medication known to influence intestinal permeability
- •Excessive alcohol usage (>20 standard units per week)
- •Not capable of signing an informed consent
结局指标
主要结局
Change in Transepithelial electircal resistance
时间窗: 2 hours
次要结局
- Change in permeation of a fluorescent marker(2 hours)