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NCT06065228 Clinical Trial

Therapeutic Endpoint in Pediatric IBD Conditions

Crohn Disease Clinical Trial

Official title:
Development of a Therapeutic Endpoint in Pediatric IBD Conditions

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06065228
Other study ID # STUDY00000658
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 27, 2023
Est. completion date December 2025

Study information
Verified date February 2024
Source Children's National Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 6 Years to 21 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• AlgometRx Nociometer
Physiologic characterization of disease activity

Locations
Country Name City State
United States Children's National Health System Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary objective of this study is the measurement of the nociceptive index for clinical output. 1 Year
Secondary The secondary objective of this study is the characterization of the nociceptive index in IBD populations in response to standard of care interventions. 1 Year
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