Assessment of Colonic Epithelial Integrity With Mucosal Impedance

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Assessment of Colonic Epithelial Integrity With Mucosal Impedance

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Diagnostic Test: mucosal impedance (MI) testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inflammatory Bowel Disease<br>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<br>* 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.<br>|
| control<br>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<br>* 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.<br>|

What is the study measuring?
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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 |