跳至主要内容
临床试验/NCT03152279
NCT03152279已完成不适用

Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
mucosal impedance values

研究概览

简要总结

Increased intestinal permeability can represent compromise of the epithelium's integrity and is thought to be the primary mechanism in patients who develop Celiac Disease (CeD) and non-celiac gluten sensitivity when gluten peptides cross the barrier and trigger an immune response. In this study, the investigators propose to use a novel, minimally invasive technology to detect mucosal damage (i.e. barrier dysfunction) in the duodenal epithelium. The primary aim of this study is to identify if there is a difference in duodenal mucosal impedance between CeD and control patients.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled for endoscopy as part of routine care with or without suspected Celiac Disease based upon at least 1 positive serologic marker of CeD
  • consuming gluten at time of endoscopy

排除标准

  • Already on a gluten free diet or unwilling to undergo a gluten challenge
  • Undergoing upper endoscopy for an urgent indication such as unstable gastrointestinal bleed or food impaction
  • Patients with inflammatory bowel disease
  • Patients on blood thinners other than aspirin at time of endoscopy
  • Patient unable to give informed consent
  • Patient less than 18 years old

结局指标

主要结局

mucosal impedance values

时间窗: Values will be obtained at conclusion of esophagogastroduodenoscopy (EGD), an expected average of 6 minutes

Identify if there is a difference in duodenal mucosal impedance between CeD and control patients

次要结局

  • Marsh Score(1 week)
  • IFABP(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dhyanesh Patel

Principal Investigator

Vanderbilt University Medical Center

研究点 (1)

Loading locations...

相似试验