Therapeutic Endpoint in Pediatric IBD Conditions

Recruiting now

Conditions studied: Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease

In brief

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.

Key facts

Study ID

NCT06065228

Run by

Children's National Research Institute

People needed

60

Starts

2023-11-27

Expected to finish

2027-12-01

Last updated by the study team

2026-04-08

Who can join

Age: 6 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 6 years of age at screening.
• Documentation of an IBD diagnosis as evidenced by history

You may not qualify if…

• 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 is running

• Children's National Health System — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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