Therapeutic Endpoint in Pediatric IBD Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-21
SponsorChildren's National Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female ≥ 6 years of age at screening.
Documentation of an IBD diagnosis as evidenced by history
Disqualifiers
Documented history of eye disease precluding pupillometry
Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.
Trial population
This study proposes to enroll patients diagnosed with IBD in a longitudinal design.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AlgometRx Nociometer
DevicePhysiologic characterization of disease activity
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: UC1 intervention
Group B: CD1 intervention
Trial outcomes
Primary outcomes
1
The primary objective of this study is the measurement of the nociceptive index for clinical output.
Time frame
1 YearSecondary 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 YearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov