Therapeutic Endpoint in Pediatric IBD Conditions

Recruiting

• Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease
• Interventions: Other: AlgometRx Nociometer

• Registration Number: NCT06065228
• Lead Sponsor: Children's National Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-09-27
• Study First Posted: 2023-10-03
• Study Start: 2023-11-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UC	AlgometRx Nociometer	-
CD	AlgometRx Nociometer	-

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is the measurement of the nociceptive index for clinical output.	1 Year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children's National Health System; 🇺🇸 Washington, District of Columbia, United States