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Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

NCT03152279 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2021-05-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Dhyanesh Patel, MD · Vanderbilt University Medical Center

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-11-07
Completion
2018-11-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03152279 on ClinicalTrials.gov