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New treatment option for Ulcerative Colitis
Official title Nicotinamide Riboside in Ulcerative Colitis
ClinicalTrials.gov ID: NCT05561738
What this study is testing
- What it's testing
- This is a randomized, double-blind pilot study of Nicotinamide Riboside (NR) in Pediatric-onset Ulcerative Colitis (UC).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- Pediatric patients (≤18yo);
- Diagnosis of mild to moderate ulcerative colitis as determined by Pediatric Ulcerative Colitis Activity Index (PUCAI) and endoscopic scoring (Mayo)...
- Although the investigators will target newly diagnosed patients (therefore, treatment naïve), patients with established disease will also be enrolled.
You likely can't join if
- 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...
- Patients who have other chronic inflammatory/autoimmune disorders or prior malignancy;
See the full eligibility 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.
- 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...
- 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, people with platelets \<50,000 do not undergo endoscopy and, therefore, are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.