Assessment of Colonic Epithelial Integrity With Mucosal Impedance

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Diagnostic Test: mucosal impedance (MI) testing

• Registration Number: NCT03165058
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

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 .

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-24
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Results First Submitted: 2020-05-19
• Results First Submitted QC: 2020-05-19
• Results First Posted: 2020-06-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	mucosal impedance (MI) testing	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.
Inflammatory Bowel Disease	mucosal impedance (MI) testing	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.

Primary Outcome Measures

Name	Time	Method
Mucosal Impedance Values	15 minutes	compare the mucosal impedance values between subjects with IBD and controls

Secondary Outcome Measures

Name	Time	Method
Difference in Inflamed and Normal Mucosa	15 minutes	compare the mucosal impedance values in inflamed and normal areas in IBD patients

Trial Locations

Locations (1)

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