Therapeutic Endpoint in Pediatric IBD Conditions
Purpose
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.
Conditions
- Inflammatory Bowel Diseases
- Colitis, Ulcerative
- Crohn Disease
Eligibility
- Eligible Ages
- Between 6 Years and 21 Years
- Eligible Genders
- All
- Accepts 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| UC |
|
|
| CD |
|
Recruiting Locations
Children's National and nearby locations
Children's National Health System
Washington, District of Columbia 20010
Washington, District of Columbia 20010
More Details
- NCT ID
- NCT06065228
- Status
- Recruiting
- Sponsor
- Children's National Research Institute