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
Qualifiers
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 design
Treatments tested in this trial
- AlgometRx Nociometer
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
1Children's National Health System20010, Washington D.C.District of Columbia, United States
Sponsors and collaborators
Children's National Research Institute
Lead sponsor
Source ClinicalTrials.gov