Therapeutic Endpoint in Pediatric IBD Conditions

Children's National Research Institute60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Inflammatory Bowel Diseases Colitis, Ulcerative Crohn Disease

Interventions

AlgometRx NociometerDEVICE

Physiologic characterization of disease activity

Eligibility

Sex: ALLMin age: 6 YearsMax age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The primary objective of this study is the measurement of the nociceptive index for clinical output.

Time frame: 1 Year

Secondary Outcomes

The secondary objective of this study is the characterization of the nociceptive index in IBD populations in response to standard of care interventions.