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NCT Number: NCT06065228

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.

Recruiting

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Health System

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

Location status: Recruiting

Location contact

Julia C Finkel, MD

CONTACT

[email protected]

(888) 884-2327

Julia C Finkel, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AlgometRx Nociometer

Device

Physiologic characterization of disease activity

Primary outcomes

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

    Time frame: 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.

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Registry information

Official study title

Development of a Therapeutic Endpoint in Pediatric IBD Conditions

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 3, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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