Therapeutic Endpoint in Pediatric IBD Conditions

NCT06065228 | Recruiting FDA Device

• 1 other identifier: STUDY00000658
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Outcome Measures

Primary Outcomes (1)

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

  1 Year

Secondary Outcomes (1)

• 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

Study Arms (2)

UC

Device: AlgometRx Nociometer

CD

Device: AlgometRx Nociometer

Interventions

AlgometRx Nociometer DEVICE

Physiologic characterization of disease activity

CD; UC

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male or female ≥ 6 years of age at screening.
• Documentation of an IBD diagnosis as evidenced by history

You may not qualify if:

• Documented history of eye disease precluding pupillometry
• Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Pediatrics

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 3, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)