New hope for kids with colitis: budesonide pill trial aims for remission

NCT ID NCT04314375

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether budesonide extended-release tablets can safely help children aged 5 to 17 with mild to moderate ulcerative colitis achieve remission. About 70 participants will receive either a low dose, high dose, or placebo for 56 days. The goal is to reduce symptoms like rectal bleeding and frequent stools, with an endoscopic check to confirm improvement.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

budesonide extended-release tablets

What this could lead to

If successful, this could provide a treatment option for children with mild to moderate ulcerative colitis to achieve remission without needing stronger drugs.

What could go wrong

This is a phase 4 study with only 70 participants, so results may not apply to all children. Budesonide is a steroid and can have side effects like growth suppression or hormonal changes.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Bausch Health Site 003

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Bausch Health Site 006

    RECRUITING

    The Bronx, New York, 10467, United States

  • Bausch Health Site 008

    RECRUITING

    Garden Grove, California, 92845, United States

  • Bausch Health Site 010

    RECRUITING

    Greenville, North Carolina, 27834, United States