Nicotinamide Riboside for treating Ulcerative Colitis in children
Nicotinamide Riboside in Ulcerative Colitis
This study is testing if a supplement called Nicotinamide Riboside can help children with Ulcerative Colitis feel better by improving their gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05561738 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of Nicotinamide Riboside (NR) on pediatric patients with Ulcerative Colitis (UC). It is a randomized, double-blind trial aimed at assessing the feasibility of NR supplementation to improve mitochondrial function and metabolic balance in the intestinal epithelium. The study will evaluate how NR affects NAD+ levels and mitochondrial structure/function in these patients. Participants will receive either NR, a placebo, or standard care.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 18 years or younger with mild to moderate Ulcerative Colitis.
Not a fit: Patients with acute severe Ulcerative Colitis or those with concurrent gastrointestinal infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the management of Ulcerative Colitis in pediatric patients by restoring mitochondrial function.
How similar studies have performed: While this approach is novel in the context of pediatric Ulcerative Colitis, similar studies in other conditions have shown promise with NAD+ repletion strategies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kevin Mollen — University of Pittsburgh
- Study coordinator: Min Shi
- Email: shim@upmc.edu
- Phone: 412-692-6272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.