NCT06065228 Therapeutic Endpoint in Pediatric IBD Conditions
| NCT ID | NCT06065228 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's National Research Institute |
| Condition | Inflammatory Bowel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
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.