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临床试验/NCT02699333
NCT02699333已完成不适用

Risk Factors for Microscopic Colitis

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 346 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
346
试验地点
1
主要终点
Microscopic Colitis

研究概览

简要总结

Microscopic colitis is a common cause of watery diarrhea, particularly in the elderly. Although the incidence is comparable to ulcerative colitis and Crohn's disease, the etiology is unknown. Understanding the etiology of microscopic colitis is an important step in developing logical interventions to decrease the burden from microscopic colitis. This research could provide critical insights into the etiology of this poorly studied condition.

详细描述

Microscopic colitis (MC) is a chronic condition that is a common cause of watery diarrhea, particularly in the elderly. The etiology is unknown but widely considered to be an abnormal immune reaction to luminal antigens in predisposed hosts. Drugs and autoimmunity have also been implicated. The aims of the study are: 1) To quantitatively classify microscopic colitis using image analysis microscopy to determine whether the degree of lymphocytic infiltration correlates with etiology, symptoms and prognosis. 2) To investigate the etiology of microscopic colitis by examining medical and lifestyle risk factors including medications, autoimmunity, diet, and smoking 3) To evaluate the association between the adherent microbial flora and MC to assess whether bacterial dysbiosis is linked to presence of MC. As an exploratory aim we will evaluate whether CYP2C19 polymorphisms are more common in purportedly drug-induced disease since the diverse drugs that have been associated with MC are all substrates for this gene.

To conduct the study the investigators will obtain detailed dietary, medical and lifestyle information on study subjects who undergo complete colonoscopy for diarrhea. The investigators will obtain colon biopsies from the right, transverse and left colon to evaluate adherent bacterial organisms. The investigators will draw blood to evaluate CYP2C19 polymorphisms and for future genetic studies. The prospective design corrects important limitations of prior research on MC. Successful completion of the study aims will improve the understanding of risk factors, set the stage for more scientifically grounded future research, and potentially suggest new interventions for a disease that is currently poorly understood.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colonoscopy for diarrhea

排除标准

  • Fewer than 4 loose bowel movements per day.
  • Failure to visualize the entire colon to the cecum or preparation less than good or excellent.
  • Age under 35 years. There will be no upper age limit.
  • Inability to understand and cooperate with the interview.
  • Indication for colonoscopy other than diarrhea.
  • Prior history of inflammatory bowel disease (Crohn's disease or ulcerative colitis).

结局指标

主要结局

Microscopic Colitis

时间窗: Day 1

Microscopic colitis defined by increased lymphocytes or collagen

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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