RECRUITING

Nicotinamide Riboside in Ulcerative Colitis

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized, double-blind pilot study of Nicotinamide Riboside (NR) in Pediatric-onset Ulcerative Colitis (UC).

Official Title

Nicotinamide Riboside in Ulcerative Colitis

Quick Facts

Study Start:2024-02-28

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05561738

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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 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.

Inclusion Criteria

Exclusion 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 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.

Contacts and Locations

Study Contact

Min Shi

CONTACT

412-692-6272

shim@upmc.edu

Principal Investigator

Kevin Mollen

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

Kevin Mollen, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-28

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-02-28

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Ulcerative Colitis