NCT05561738 Nicotinamide Riboside in Ulcerative Colitis
| NCT ID | NCT05561738 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-02-28 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-02-28 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized, double-blind pilot study of Nicotinamide Riboside (NR) in Pediatric-onset Ulcerative Colitis (UC).
Eligibility Criteria
Inclusion Criteria: * Pediatric patients (≤18yo); * Diagnosis of mild to moderate ulcerative colitis as determined by Pediatric Ulcerative Colitis Activity Index (PUCAI) and endoscopic scoring (Mayo) at the time of colonoscopy; * Although the investigators will target newly diagnosed patients (therefore, treatment naïve), patients with established disease will also be enrolled. 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 past three months. Patients on Biologic medications may be enrolled if their dose has been stable for at least three months. Final determination of eligibility will be at the discretion of the treating investigator. After the initiation of the study, subjects may receive any medication to treat their disease as dictated by their care providers; * Patients who have other chronic inflammatory/autoimmune disorders or prior malignancy; * Pregnant women (All women of childbearing age will be required to use contraception at the time of inclusion). * Patients with existing renal or hepatic dysfunction; * Per standard of care guidance, subjects with platelets \<50,000 do not undergo endoscopy and, therefore, are not eligible.
Contact & Investigator
Kevin Mollen
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05561738 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05561738 currently recruiting?
Yes, NCT05561738 is actively recruiting participants. Contact the research team at shim@upmc.edu for enrollment information.
Where is the NCT05561738 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05561738 clinical trial?
NCT05561738 is sponsored by University of Pittsburgh. The principal investigator is Kevin Mollen at University of Pittsburgh. The trial plans to enroll 40 participants.
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