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Therapeutic Endpoint in Pediatric IBD Conditions | Clinical Trials | Clareo Health

RECRUITING

Therapeutic Endpoint in Pediatric IBD Conditions

Development of a Therapeutic Endpoint in Pediatric IBD Conditions

NCT06065228•Children's National Research Institute

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.

Eligibility

Age

6 - 21 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Children's National Health System

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

Key Dates

Start Date

November 27, 2023

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

July 8, 2025

Enrollment

ESTIMATED participants

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Interventions

AlgometRx Nociometer

OTHER

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE2/PHASE3

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

NCT05076175

Colitis, Ulcerative

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Therapeutic Endpoint in Pediatric IBD Conditions

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Immunological Characteristics of Preclinical IBD

Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study