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Completed

NCT Number: NCT03165058

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal 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

About this study

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 .

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

mucosal impedance (MI) testing

Diagnostic Test

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.

Primary outcomes

  1. Mucosal Impedance Values

    Time frame: 15 minutes

    compare the mucosal impedance values between subjects with IBD and controls

Secondary outcomes

  1. Difference in Inflamed and Normal Mucosa

    Time frame: 15 minutes

    compare the mucosal impedance values in inflamed and normal areas in IBD patients

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 24, 2017
Registry last updated
May 7, 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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