Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance
2021年5月5日 更新者：Dhyanesh Patel、Vanderbilt University Medical Center
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.
研究概览
研究类型
观察性的
注册 (实际的)
33
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt University Medical Center Endoscopy Laboratory
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 99年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Celiac disease patients will be identified in the Celiac Disease Clinic at Vanderbilt.
Patients will be asked if they would like to participate in the study during their clinic visit and will undergo consent for the study at the time of procedure.
Control subjects will be asked about participation at the time of routine endoscopy.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：病例对照
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Celiac Disease
Patients with suspected Celiac Disease who plan to undergo duodenal biopsy as part of routine clinical care
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During routine endoscopy, consented study participants will have a mucosal impedance catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.
The study procedure will add approximately 1-2 minutes of anesthesia time for each participant.
At time of endoscopy, subjects with initial positive CeD serology will have a blood sample taken for any missing CeD serologies and intestinal fatty acid-binding protein (IFABP).
This will be done at time of IV initiation as to avoid any additional venipuncture.
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Control
Patients scheduled for an upper endoscopy for indication other than evaluation of Celiac Disease or concern for CeD as part of routine clinical care
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During routine endoscopy, consented study participants will have a mucosal impedance catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.
The study procedure will add approximately 1-2 minutes of anesthesia time for each participant.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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mucosal impedance values
大体时间：Values will be obtained at conclusion of esophagogastroduodenoscopy (EGD), an expected average of 6 minutes
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Identify if there is a difference in duodenal mucosal impedance between CeD and control patients
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Values will be obtained at conclusion of esophagogastroduodenoscopy (EGD), an expected average of 6 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Marsh Score
大体时间：1 week
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Correlate measures of duodenal impedance with standardized pathology scores in CeD (Marsh Score)
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1 week
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IFABP
大体时间：1 week
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Identify whether there is a difference in IFABP in patients with normal and abnormal mucosal impedance
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1 week
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年12月1日
初级完成 (实际的)
2018年11月7日
研究完成 (实际的)
2018年11月14日
研究注册日期
首次提交
2017年5月10日
首先提交符合 QC 标准的
2017年5月12日
首次发布 (实际的)
2017年5月15日
研究记录更新
最后更新发布 (实际的)
2021年5月6日
上次提交的符合 QC 标准的更新
2021年5月5日
最后验证
2021年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Mucosal Impedance Catheter的临床试验
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Charles University, Czech RepublicUniversity Hospital Olomouc; General University Hospital, Prague; Cardiocenter Podlesí, Trinec...终止