Recruiting

Pediatric IBD

Sponsor:

Children's National Research Institute

Code:

NCT06065228

Conditions

Inflammatory Bowel Diseases

Colitis, Ulcerative

Crohn Disease

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

Interventions

AlgometRx Nociometer

Study Details

Brief 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.

Conditions

Inflammatory Bowel Diseases

Colitis, Ulcerative

Crohn Disease

Study ID

NCT06065228

Start date

Nov 27, 2023

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

UC

CD

Interventions

AlgometRx Nociometer

Physiologic characterization of disease activity

Primary outcome measure

  • The primary objective of this study is the measurement of the nociceptive index for clinical output. [ Time Frame: 1 Year ]

Central Contacts and Locations

Locations

Children's National Health System

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Julia C Finkel, MD

(888) 884-2327jcfinkel@cnmc.org

Principal Investigator:

Julia C Finkel, MD

More Information

Sponsor

Children's National Research Institute

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2026-04-08.