Therapeutic Endpoint in Pediatric IBD Conditions
Observational · No treatment assigned · 1 site · Children's National Research Institute
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases, Colitis, Ulcerative and Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 6 to 21
- Any sex
Some of the main requirements, copied from the record:
- Male or female ≥ 6 years of age at screening.
- Documentation of an IBD diagnosis as evidenced by history
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2023-11-27.
- Main results expected around 2026-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- The primary objective of this study is the measurement of the nociceptive index for clinical output. (1 Year)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease |
| Lead sponsor | Children's National Research Institute |
| Enrollment | 60 (estimated) |
| Start date | 2023-11-27 |
| Primary completion (est.) | 2026-12 |
| First posted | 2023-10-03 |
| Last updated | 2026-04-08 |
| Official title | Development of a Therapeutic Endpoint in Pediatric IBD Conditions |
| ClinicalTrials.gov ID | NCT06065228 |
Interventions
- AlgometRx Nociometer (Device)
Physiologic characterization of disease activity
Full eligibility criteria (from the record)
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)
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Health System | Washington D.C., District of Columbia | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.