Therapeutic Endpoint in Pediatric IBD Conditions

Children's National

Status: Enrolling

Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: AlgometRx Nociometer

Study type: Observational

Funder types: Other

Identifiers

NCT06065228

STUDY00000658

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

UC

Treatment:

Other: AlgometRx Nociometer

CD

Treatment:

Other: AlgometRx Nociometer