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OpenTrials
Completed

NCT Number: NCT03152279

Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center Endoscopy Laboratory

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. mucosal impedance values

    Time frame: 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 outcomes

  1. Marsh Score

    Time frame: 1 week

    Correlate measures of duodenal impedance with standardized pathology scores in CeD (Marsh Score)

  2. IFABP

    Time frame: 1 week

    Identify whether there is a difference in IFABP in patients with normal and abnormal mucosal impedance

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 15, 2017
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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