Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

NCT03152279 | Completed

• 1 other identifier: 161436
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Marsh Score

  1 week

• IFABP

  1 week

Study Arms (2)

Celiac Disease

Patients with suspected Celiac Disease who plan to undergo duodenal biopsy as part of routine clinical care

Diagnostic Test: Mucosal Impedance Catheter; Diagnostic Test: Blood sample

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

Interventions

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.

Celiac Disease; Control

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.

Celiac Disease

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center Endoscopy Laboratory

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dhyanesh Patel, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 15, 2017
• Study Start: December 1, 2016
• Primary Completion: November 7, 2018
• Study Completion: November 14, 2018
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)