Development of a Therapeutic Endpoint in Pediatric IBD Conditions
Children's National Research Institute
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.
Eligibility
- Age range
- 6–21 years
- Sex
- All
- 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.
Interventions
- DeviceAlgometRx Nociometer
Physiologic characterization of disease activity
Location
- Children's National Health SystemWashington D.C., District of Columbia