Association Between Inflammatory Activities and Epithelial Gap Density in Inflammatory Bowel Disease
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:
- To determine the relationship between inflammatory activities and epithelial gaps in IBD by CLE and evaluate epithelial gaps healing via dexamethasone treatment.
- 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
- 是
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
Yanqing Li
Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University
Shandong University
