Development of a Therapeutic Endpoint in Pediatric IBD Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- The primary objective of this study is the measurement of the nociceptive index for clinical output.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to 21 Years (Child, Adult)
- Sex
- 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.
Arms & Interventions
UC
Intervention: AlgometRx Nociometer (Device)
CD
Intervention: AlgometRx Nociometer (Device)
Outcomes
Primary Outcomes
The primary objective of this study is the measurement of the nociceptive index for clinical output.
Time Frame: 1 Year
Secondary Outcomes
- 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)
Investigators
Julia Finkel
Professor of Anesthesiology and Pediatrics
Children's National Research Institute