RecruitingNCT06065228

Therapeutic Endpoint in Pediatric IBD Conditions

Development of a Therapeutic Endpoint in Pediatric IBD Conditions


Sponsor

Children's National Research Institute

Enrollment

60 participants

Start Date

Nov 27, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study looks at using a non-invasive eye test (pupillometry — measuring how the pupil responds to light) as a way to monitor disease activity in children with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. The goal is to find easier and less invasive ways to track how well treatment is working. **You may be eligible if...** - You are 6 years of age or older - You have a confirmed diagnosis of IBD (Crohn's disease or ulcerative colitis) **You may NOT be eligible if...** - You have a known eye condition that would prevent accurate pupillometry testing - You are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAlgometRx Nociometer

Physiologic characterization of disease activity


Locations(1)

Children's National Health System

Washington D.C., District of Columbia, United States

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NCT06065228


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