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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celiac Disease | Patients with suspected Celiac Disease who plan to undergo duodenal biopsy as part of routine clinical care |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucosal Impedance Catheter | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dhyanesh Patel, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center Endoscopy Laboratory | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood sample | Diagnostic Test | 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. |
|
| 1 week |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |