Therapeutic Endpoint in Pediatric IBD Conditions

• Sponsor: Children's National Research Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06065228
• Collaborator: (none)
• Enrollment: 60
• Anticipated Duration (Months): 26

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease	Other: AlgometRx Nociometer

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Development of a Therapeutic Endpoint in Pediatric IBD Conditions
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Children's National Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julia Finkel, Professor of Anesthesiology and Pediatrics, Children's National Research Institute
• ClinicalTrials.gov Identifier: NCT06065228
• Other Study ID Numbers: STUDY00000658
• First Posted: Oct 3, 2023
• Last Update Posted: Oct 3, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Crohn Disease; Inflammatory Bowel Diseases; Colitis, Ulcerative

Study Results

No Results Posted as of Oct 3, 2023