Assessment of Colonic Epithelial Integrity With Mucosal Impedance

Inflammatory Bowel Diseases Clinical Trial

Official title:

Assessment of Colonic Epithelial Integrity With Mucosal Impedance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165058
• Other study ID #: 160534
• Status: Completed
• Start date: November 2016
• Est. completion date: May 2019

Study information

• Verified date: May 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center Endoscopy Laboratory	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucosal Impedance Values	compare the mucosal impedance values between subjects with IBD and controls	15 minutes
Secondary	Difference in Inflamed and Normal Mucosa	compare the mucosal impedance values in inflamed and normal areas in IBD patients	15 minutes