跳至主要内容
临床试验/NCT01758926
NCT01758926Unknown不适用

Association Between Inflammatory Activities and Epithelial Gap Density in Inflammatory Bowel Disease

Shandong University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
gap density

研究概览

简要总结

The study aims to:

  1. To determine the relationship between inflammatory activities and epithelial gaps in IBD by CLE and evaluate epithelial gaps healing via dexamethasone treatment.
  2. To demonstrated the alteration of local barrier function in IBD using CLE.

详细描述

The primary end-point of this study was the cohort comparison of epithelial gap density and local barrier function as determined by CLE of subjects with IBD versus controls. Despite discontinuities in the cellular layer, the intestinal barrier function is maintained during this high cell turnover rate at the apical pole of the epithelial layer. Gaps first identified in vivo through acriflavine have pivotal definitions (lacked nuclei or cytosol, appeared to be filled with an impermeable substance). However, Current endoscopic technology does not identify whether there is material present in human gaps, so investigators could not formally resolve whether human epithelial gaps compromise or defend the epithelial barrier.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female aged 18-80
  • IBD: Patients previously diagnosed as having IBD
  • Health control: Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.
  • Subjects who experienced successful intubation of the terminal ileum.

排除标准

  • Subjects age < 18 or >80 years
  • Subjects under conditions unsuitable for performing CLE including coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 s), cirrhosis, renal dysfunction (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, acute gastrointestinal bleeding, jaundice and known allergy to fluorescein sodium.

结局指标

主要结局

gap density

时间窗: 6 months

the distributions of gap density

次要结局

  • local barrier function(6 months)

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanqing Li

Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University

Shandong University

研究点 (1)

Loading locations...

相似试验