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Therapeutic Endpoint in Pediatric IBD Conditions
NCT06065228 · Children's National Research Institute
In plain English
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Official title
Development of a Therapeutic Endpoint in Pediatric IBD Conditions
About this study
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.
Study design
Enrollment target: 60 participants
Age groups: child, adult
Timeline
Starts: 2023-11-27
Estimated completion: 2027-12
Last updated: 2026-04-08
Interventions
Device: AlgometRx Nociometer
Primary outcomes
- • The primary objective of this study is the measurement of the nociceptive index for clinical output. (1 Year)
Sponsor
Children's National Research Institute · other
All locations (1)
Children's National Health SystemRecruiting
Washington D.C., District of Columbia, United States