Clinical trial Recruiting at 1 site Observational Ages 6 to 21

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 typeObservational
Ages6 Years to 21 Years
SexAll
Enrollment60 (estimated)
SponsorChildren's National Research Institute
Academic / other
Locations1 site (Washington D.C., District of Columbia)
StatusRecruiting
StartedNovember 27, 2023
Main results expectedDecember 2026
Study endsDecember 2027
Registry record updatedApril 8, 2026
Trial IDNCT06065228 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

  • 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.