Inflammatory Bowel DiseasesNCT06065228
Therapeutic Endpoint in Pediatric IBD Conditions
An observational study of Inflammatory Bowel Diseases and Colitis, Ulcerative, run by Children's National Research Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- What is being tested?
- AlgometRx Nociometer
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study proposes to enroll patients diagnosed with IBD in a longitudinal design.
Who may be able to join
- Male or female ≥ 6 years of age at screening.
- Documentation of an IBD diagnosis as evidenced by history
Who cannot join
- Documented history of eye disease precluding pupillometry
- Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Health System
Washington D.C., District of Columbia, 20010
Julia C Finkel, MD, (888) 884-2327, jcfinkel@cnmc.org
Julia C Finkel, MD
About this study
Official title: Development of a 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.
- Being tested
- AlgometRx Nociometer
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgometRx NociometerDevice
Physiologic characterization of disease activity
| Study group | Role | What they receive |
|---|---|---|
| UC | Not described Receives: Device: AlgometRx Nociometer | |
| CD | Not described Receives: Device: AlgometRx Nociometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is the measurement of the nociceptive index for clinical output.
Measured: 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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start27 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Finkel, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065228
- Sponsor's protocol ID
- STUDY00000658
- Status last verified
- Apr 2026
- First submitted
- 27 Sep 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Therapeutic Endpoint in Pediatric IBD Conditions
- ClinicalTrials.gov ID
- NCT06065228
- Acronym / sponsor ID
- STUDY00000658
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC | – | Device: AlgometRx Nociometer |
| CD | – | Device: AlgometRx Nociometer |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study proposes to enroll patients diagnosed with IBD in a longitudinal design.
Key inclusion criteria (2 listed)
- Male or female ≥ 6 years of age at screening.
- Documentation of an IBD diagnosis as evidenced by history
Key exclusion criteria (2 listed)
- Documented history of eye disease precluding pupillometry
- Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlgometRx NociometerPhysiologic characterization of disease activity | Device | CD, UC |
Primary outcome
The primary objective of this study is the measurement of the nociceptive index for clinical output.
Time frame: 1 Year
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Inflammatory Bowel Diseases
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingPhase 1
A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis
Colitis, Ulcerative
RecruitingPhase 2
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Inflammatory Bowel Diseases, Crohn's Disease
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Colitis, Ulcerative, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is the measurement of the nociceptive index for clinical output. (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.