Therapeutic Endpoint in Pediatric IBD Conditions

NCT ID: NCT06065228

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-27

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Inflammatory Bowel Diseases Colitis, Ulcerative Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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UC

AlgometRx Nociometer

Intervention Type OTHER

Physiologic characterization of disease activity

CD

AlgometRx Nociometer

Intervention Type OTHER

Physiologic characterization of disease activity

Interventions

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AlgometRx Nociometer

Physiologic characterization of disease activity

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's National Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Julia Finkel

Professor of Anesthesiology and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's National Health System

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

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Julia C Finkel, MD

Role: primary

888-884-2327

Other Identifiers

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STUDY00000658

Identifier Type: -

Identifier Source: org_study_id

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