Inflammatory Bowel Diseases
Conditions
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 .
Interventions
DIAGNOSTIC_TESTmucosal 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.
Sponsors
Vanderbilt University Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal Impedance Values | 15 minutes | compare the mucosal impedance values between subjects with IBD and controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Inflamed and Normal Mucosa | 15 minutes | compare the mucosal impedance values in inflamed and normal areas in IBD patients |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 21 |
| 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.
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. | 11 |
| Total | 32 |
Baseline characteristics
| Characteristic | Inflammatory Bowel Disease | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 7 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 11 Participants | 29 Participants |
| Region of Enrollment United States | 21 participants | 11 participants | 32 participants |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 18 Participants |
| Sex: Female, Male Male | 9 Participants | 5 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 11 |
| other Total, other adverse events | 0 / 21 | 0 / 11 |
| serious Total, serious adverse events | 0 / 21 | 0 / 11 |
Outcome results
Primary
Mucosal Impedance Values
compare the mucosal impedance values between subjects with IBD and controls
Time frame: 15 minutes
Population: Analysis is missing for 4 participants from each group either due to incomplete mucosal impedance (MI) readings or indeterminate disease status.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Inflammatory Bowel Disease | Mucosal Impedance Values | Left Colon | 673 ohms |
| Inflammatory Bowel Disease | Mucosal Impedance Values | Right Colon | 1139 ohms |
| Inflammatory Bowel Disease | Mucosal Impedance Values | Rectum | 767 ohms |
| Inflammatory Bowel Disease | Mucosal Impedance Values | Transverse Colon | 891 ohms |
| Control | Mucosal Impedance Values | Rectum | 531 ohms |
| Control | Mucosal Impedance Values | Right Colon | 849 ohms |
| Control | Mucosal Impedance Values | Left Colon | 699 ohms |
| Control | Mucosal Impedance Values | Transverse Colon | 783 ohms |
Secondary
Difference in Inflamed and Normal Mucosa
compare the mucosal impedance values in inflamed and normal areas in IBD patients
Time frame: 15 minutes
Population: There were no patients where inflamed mucosa was directly adjacent to normal mucosa to be able to measure impedance in both