Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Conditions
Brief summary
The purpose of this clinical study is the development of physiologic endpoint of inflammation in pediatric patients diagnosed with inflammatory bowel disease (IBD), specifically subtypes Crohn's disease (CD) and ulcerative colitis (UC). The novel medical device evaluates the patient's sensory response to each of the three sensory nerve fiber types. Data from the device provides an assessment of disease activity and a more precise approach to treatment.
Interventions
DEVICEAlgometRx Nociometer
Physiologic characterization of disease activity
Sponsors
Children's National Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 6 years of age at screening. * Documentation of an IBD diagnosis as evidenced by history
Exclusion criteria
* Documented history of eye disease precluding pupillometry * Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is the measurement of the nociceptive index for clinical output. | 1 Year |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is the characterization of the nociceptive index in IBD populations in response to standard of care interventions. | 1 Year |
Countries
United States
Outcome results
None listed