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Therapeutic Endpoint in Pediatric IBD Conditions

RecruitingObservational study

Development of a Therapeutic Endpoint in Pediatric IBD Conditions

Who can join

Ages 6 to 21 · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Children's National Research Institute · Participants: 60 · Started: Nov 27, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06065228

Locations in the U.S.

District of ColumbiaChildren's National Health System, Washington D.C.

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.