Therapeutic Endpoint in Pediatric IBD Conditions

Development of a Therapeutic Endpoint in Pediatric IBD Conditions

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 Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative
• Intervention / Treatment: Other: AlgometRx Nociometer

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • Children's National Health System
      • Contact: Julia C Finkel, MD; Phone Number: 888-884-2327; Email: jcfinkel@cnmc.org
      • Principal Investigator: Julia C Finkel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study proposes to enroll patients diagnosed with IBD in a longitudinal design.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CD	Other: AlgometRx Nociometer; Physiologic characterization of disease activity
UC	Other: AlgometRx Nociometer; Physiologic characterization of disease activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective of this study is the measurement of the nociceptive index for clinical output.	1 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's National Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Colitis; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative
• Other Study ID Numbers: STUDY00000658

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No