Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

Completed

• Conditions: Celiac Disease
• Interventions: Diagnostic Test: Mucosal Impedance Catheter; Diagnostic Test: Blood sample

• Registration Number: NCT03152279
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Primary Completion: 2018-11-07
• Study Completion: 2018-11-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Celiac Disease	Mucosal Impedance Catheter	Patients with suspected Celiac Disease who plan to undergo duodenal biopsy as part of routine clinical care
Celiac Disease	Blood sample	Patients with suspected Celiac Disease who plan to undergo duodenal biopsy as part of routine clinical care
Control	Mucosal Impedance Catheter	Patients scheduled for an upper endoscopy for indication other than evaluation of Celiac Disease or concern for CeD as part of routine clinical care

Primary Outcome Measures

Name	Time	Method
mucosal impedance values	Values will be obtained at conclusion of esophagogastroduodenoscopy (EGD), an expected average of 6 minutes	Identify if there is a difference in duodenal mucosal impedance between CeD and control patients

Secondary Outcome Measures

Name	Time	Method
Marsh Score	1 week	Correlate measures of duodenal impedance with standardized pathology scores in CeD (Marsh Score)
IFABP	1 week	Identify whether there is a difference in IFABP in patients with normal and abnormal mucosal impedance

Trial Locations

Locations (1)

Vanderbilt University Medical Center Endoscopy Laboratory; 🇺🇸 Nashville, Tennessee, United States