Evaluating inflammation in children with inflammatory bowel disease
Development of a Therapeutic Endpoint in Pediatric IBD Conditions
This study is testing a new device to see how it can help doctors understand inflammation in children with Crohn's disease and ulcerative colitis, so they can provide better treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 21 Years |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06065228 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a physiological endpoint for inflammation in pediatric patients diagnosed with inflammatory bowel diseases, specifically Crohn's disease and ulcerative colitis. It utilizes a novel medical device, the AlgometRx Nociometer, to assess the sensory response of patients to different types of nerve fibers. The data collected will help evaluate disease activity and guide more precise treatment approaches for these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 years and older who have a documented diagnosis of inflammatory bowel disease.
Not a fit: Patients with a history of eye disease that affects pupillometry or those unable to participate due to developmental delays or psychological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for children suffering from inflammatory bowel diseases.
How similar studies have performed: While this approach is innovative, similar studies focusing on physiological endpoints in IBD have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Washington D.C., District of Columbia
- Children's National Health System — Washington D.C., District of Columbia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.