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Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03152279
Enrollment
33
Registered
2017-05-15
Start date
2016-12-31
Completion date
2018-11-14
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

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.

Interventions

DIAGNOSTIC_TESTMucosal 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_TESTBlood 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.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
mucosal impedance valuesValues will be obtained at conclusion of esophagogastroduodenoscopy (EGD), an expected average of 6 minutesIdentify if there is a difference in duodenal mucosal impedance between CeD and control patients

Secondary

MeasureTime frameDescription
Marsh Score1 weekCorrelate measures of duodenal impedance with standardized pathology scores in CeD (Marsh Score)
IFABP1 weekIdentify whether there is a difference in IFABP in patients with normal and abnormal mucosal impedance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026