Plain-English translation of NCT04314375 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Ulcerative Colitis research guide →Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.
This trial is testing budesonide extended-release tablets to see if it can help children and teenagers with ulcerative colitis feel better and reduce their symptoms. Ulcerative colitis is an inflammatory bowel condition that causes pain, bleeding, and diarrhea. Some children in this study will receive the medication at a lower dose, some at a higher dose, and some will receive a placebo (a pill with no active ingredient) so doctors can compare how well the treatment works.
Right now, there aren't many treatment options specifically tested and approved for children with mild-to-moderate ulcerative colitis. This medication has helped adults, but doctors need to find out if it is safe and effective for younger patients.
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If you join this study, you will be randomly assigned to receive either a low dose of the medication, a high dose, or a placebo—and neither you nor your doctor will know which one you're getting at first. You will take the medication by mouth as a tablet for several weeks while doctors monitor your symptoms through office visits and check-ups. Some visits may include blood tests or a scope exam to see how your colon is healing. Throughout the study, you can continue taking any other ulcerative colitis medication you are already on.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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