NCT03152279

Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

• Celiac Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-11-07
• Completion: 2018-11-14
• First posted: 2017-05-15
• Last updated: 2021-05-06

Locations

1 site across 1 country: United States