RECRUITING

Therapeutic Endpoint in Pediatric IBD Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Development of a Therapeutic Endpoint in Pediatric IBD Conditions

Quick Facts

Study Start:2023-11-27
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06065228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female ≥ 6 years of age at screening.
  2. * Documentation of an IBD diagnosis as evidenced by history
  1. * Documented history of eye disease precluding pupillometry
  2. * Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.

Contacts and Locations

Study Locations (Sites)

Children's National Health System
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-11-27
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Inflammatory Bowel Diseases
  • Colitis, Ulcerative
  • Crohn Disease