Evaluating inflammation in children with inflammatory bowel disease
Official title: Development of a Therapeutic Endpoint in Pediatric IBD Conditions
Run by Children's National Research Institute · NCT06065228 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 6 Years to 21 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | November 27, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT06065228 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 6 years and older who have a documented diagnosis of inflammatory bowel disease.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies focusing on physiological endpoints in IBD have shown promise, suggesting potential for success.
Who can join: the full rules
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 it's running
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Children's National Health System
Washington D.C., District of Columbia, United States Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests how much guselkumab is present in the breast milk of lactating women who are already receiving guselkumab for their approved conditions.
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Guselkumab use in Crohn's disease and ulcerative colitis
This study looks at how long people with moderate-to-severe Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.