Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance
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
- 否
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
Dhyanesh Patel
Principal Investigator
Vanderbilt University Medical Center
