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

NCT ID NCT04314375

Recruiting now Disease control Sponsor: Bausch Health Americas, Inc. Source: ClinicalTrials.gov ↗

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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.

ULCERATIVE COLITIS

Contacts and locations

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

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