Assessment of Colonic Epithelial Integrity With Mucosal Impedance

In this study, the investigators propose to use mucosal impedance (MI), a minimally invasive technology, to detect mucosal damage (i.e. barrier dysfunction) based on mucosal conductivity changes in the colonic epithelium.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Diagnostic test: mucosal impedance (MI) testing

Detailed Description

The intestinal epithelium functions to separate luminal contents from the interstitium. Increased intestinal permeability can represent compromise of the epithelium's integrity. Prior research has demonstrated that defects in intestinal barrier function are associated with inflammatory bowel disease (IBD) and increased intestinal permeability can be important in the maintenance of remission in IBD patients. There is currently not a convenient way to measure colonic epithelial barrier function in real time which could provide clinically relevant information .

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center Endoscopy Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified by physicians in the endoscopy center at Vanderbilt. Those patients undergoing colonoscopy for either the indication of screening colonoscopy or IBD surveillance will be asked, on the day of their colonoscopy, whether they want to participate in the study.

Description

Inclusion Criteria:

• Men and women over the age of 18 with a diagnosis of IBD (Ulcerative Colitis or Crohn's Disease)
• Men and women undergoing screening colonoscopy (typical age would be 50 or greater but there are exceptions)

Exclusion Criteria:

• Age less than 18 years old
• Patients unable to give informed consent
• Patients with history of colonic surgeries
• Patients with history of colonic motility disorder

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inflammatory Bowel Disease; Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.	Diagnostic test: mucosal impedance (MI) testing; During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.
control; Patients undergoing standard of care colonoscopy for age appropriate screening will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.	Diagnostic test: mucosal impedance (MI) testing; During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucosal Impedance Values	compare the mucosal impedance values between subjects with IBD and controls	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Inflamed and Normal Mucosa	compare the mucosal impedance values in inflamed and normal areas in IBD patients	15 minutes

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Yash Choksi, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: 160534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No