Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

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.

Study Overview

• Status: Completed
• Conditions: Celiac Disease
• Intervention / Treatment: Diagnostic test: Mucosal Impedance Catheter; Diagnostic test: Blood sample

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center Endoscopy Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Celiac Disease; Patients with suspected Celiac Disease who plan to undergo duodenal biopsy as part of routine clinical care	Diagnostic test: Mucosal Impedance Catheter; 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.; Diagnostic test: Blood sample; 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.
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	Diagnostic test: Mucosal Impedance Catheter; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): November 7, 2018
• Study Completion (Actual): November 14, 2018

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: 161436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No