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Therapeutic Endpoint in Pediatric IBD Conditions

Development of a Therapeutic Endpoint in Pediatric IBD Conditions

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 21 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new device to measure signs of inflammation in children with inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis. The device checks responses from three types of nerves that sense things, to help assess how active the disease is and guide treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 6 or older at the screening visit.
  • Medical history shows a diagnosis of IBD, a condition that causes swelling and irritation in the gut.

Who can't join

  • A history of eye disease that prevents measuring how the pupil—the dark center of the eye—responds.
  • Unwilling or unable to take part because of developmental delays or a current mental health condition.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

DC