Phase
Condition
Ulcerative Colitis
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Standard of Care
Nicotinamide Riboside Chloride
Placebo
Clinical Study ID
Ages < 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pediatric patients (≤18yo);
Diagnosis of mild to moderate ulcerative colitis as determined by PediatricUlcerative Colitis Activity Index (PUCAI) and endoscopic scoring (Mayo) at the timeof colonoscopy;
Although the investigators will target newly diagnosed patients (therefore,treatment naïve), patients with established disease will also be enrolled.
Exclusion
Exclusion Criteria:
Patients with acute severe ulcerative colitis;
Concurrent gastrointestinal infection (ie. Clostridium difficile, Cytomegalovirus,etc.);
A diagnosis of Crohn's disease;
Indeterminate colitis/IBD-U;
In general, patients that have been treated with steroids or antibiotics in the pastthree months. Patients on Biologic medications may be enrolled if their dose hasbeen stable for at least three months. Final determination of eligibility will be atthe discretion of the treating investigator. After the initiation of the study,subjects may receive any medication to treat their disease as dictated by their careproviders;
Patients who have other chronic inflammatory/autoimmune disorders or priormalignancy;
Pregnant women (All women of childbearing age will be required to use contraceptionat the time of inclusion).
Patients with existing renal or hepatic dysfunction;
Per standard of care guidance, subjects with platelets <50,000 do not undergoendoscopy and, therefore, are not eligible.
Study Design
Study Description
Connect with a study center
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.