Budesonide tablets for children with mild to moderate ulcerative colitis
Part of Digestive system clinical trials.
This trial studies whether budesonide extended-release tablets are safe and effective for improving symptoms in children ages 5–17 with active, mild to moderate ulcerative colitis. It also measures how the medicine moves through the body.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Child is age 5 to 17 (inclusive) at the screening visit, and weighs more than 13.6 kg at the start of the study
- A doctor has confirmed ulcerative colitis using symptoms plus scope findings and biopsy results
- Ulcerative colitis is currently active but mild to moderate (not in remission)—with bleeding, stool changes, and endoscopy findings all present
- If taking 5-ASA medicine by mouth or enema/rectal form, the dose and type must have stayed the same for at least 6 weeks, and you can keep it the same during the study
- They do not have Crohn’s disease (or an unclear “indeterminate” type), severe ulcerative colitis, or disease only limited to a very small rectal area
- They do not have recent infection causing colitis, no recent GI flare without disease activity criteria, and no prior bowel surgery other than allowed options like appendectomy or hernia repair
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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