Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

Celiac Disease Clinical Trial

Official title:

Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152279
• Other study ID #: 161436
• Status: Completed
• Start date: December 2016
• Est. completion date: November 14, 2018

Study information

• Verified date: May 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 14, 2018
• Est. primary completion date: November 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center Endoscopy Laboratory	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Marsh Score	Correlate measures of duodenal impedance with standardized pathology scores in CeD (Marsh Score)	1 week
Secondary	IFABP	Identify whether there is a difference in IFABP in patients with normal and abnormal mucosal impedance	1 week