Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

Conditions
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Celiac Disease

Intervention / Treatment
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* Diagnostic Test: Mucosal Impedance Catheter
* Diagnostic Test: Blood sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Celiac Disease<br>Patients with suspected Celiac Disease who plan to undergo duodenal biopsy as part of routine clinical care | Diagnostic Test: Mucosal Impedance Catheter<br>* 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.<br>Diagnostic Test: Blood sample<br>* 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.<br>|
| Control<br>Patients scheduled for an upper endoscopy for indication other than evaluation of Celiac Disease or concern for CeD as part of routine clinical care | Diagnostic Test: Mucosal Impedance Catheter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mucosal impedance values | Identify if there is a difference in duodenal mucosal impedance between CeD and control patients | Values will be obtained at conclusion of esophagogastroduodenoscopy (EGD), an expected average of 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marsh Score | Correlate measures of duodenal impedance with standardized pathology scores in CeD (Marsh Score) | 1 week | 
| IFABP | Identify whether there is a difference in IFABP in patients with normal and abnormal mucosal impedance | 1 week |