Crohn's Disease and Colitis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- The person being considered must be under 18 years old at the time of enrolling in the study
- They must have been diagnosed with Crohn's disease, ulcerative colitis, or a form of inflammatory bowel disease that hasn't been fully classified, based on standard medical tests
- Their body must have stopped responding to, or never responded to, at least one anti-TNF medication (a type of medication commonly used to treat inflammatory bowel disease)
- Their doctor must be planning to start them on one of these specific medications: vedolizumab, ustekinumab, risankizumab, guselkumab, mirikizumab, tofacitinib, or upadacitinib — including approved copycat versions of these medicines
- A parent or guardian must be able to give written consent in English or Spanish, and the child must be able to give their own agreement if required by local rules
Who may not be able to join:
- People whose care is expected to move to a different medical centre within the next year
- People who have previously taken any of the specific medications listed above — only those starting one of these medications for the first time after anti-TNF treatment would be considered
- People for whom any of the medications being studied are medically unsuitable (confirm with trial site)
- People with ulcerative colitis or unclassified inflammatory bowel disease who have already had their colon surgically removed
- People who currently have a stoma bag (an opening on the abdomen used to divert waste from the bowel)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Michael D Kappelman, MD, Universty of North Carolina, Chapel Hill
Phone: 833-850-2848
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Measure of Crohn's disease (CD) impact on patients' daily lives (TUMMY CD); Measures of ulcerative colitis (UC) impact on patients' daily lives (TUMMY UC); PROMIS Symptom Measure of Irritable Bowel Disease (IBD); Change in Pediatric PROMIS® Patient-Reported Outcome (PRO) Pain Interference Score for Crohn's Disease and Ulcerative Colitis (CD and UC); Change in Pediatric PROMIS® Fatigue Score for Crohn's Disease and Ulcerative Colitis (CD and UC); Change in Pediatric PROMIS® Anxiety Score for Crohn's Disease and Ulcerative Colitis (CD and UC); Change in Pediatric PROMIS® Depression Score for Cro...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.