Butyrate Therapy for Pediatric Ulcerative Colitis

This study is looking into whether butyrate enemas can help children and young adults with mild to moderate ulcerative colitis (a chronic inflammatory bowel disease). Butyrate is a natural substance made by gut bacteria that has shown promise in treating ulcerative colitis. Researchers will give butyrate enemas once a day for 12 weeks to 10 participants aged 7 to 21. The main goal is to see how many participants have an ulcerative colitis activity score less than 10 after 12 weeks, which would suggest their condition has improved. This is a feasibility study, meaning it's testing if this treatment approach is practical and shows potential. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 10 participants. It is testing butyrate enemas in children and young adults with ulcerative colitis.
What's involved
Participants will receive butyrate enemas once a day for 12 weeks. Standard management of the disease, including routine lab tests and endoscopy, will also be performed during this time.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 12 weeks, which is the duration of the treatment.

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NCT05218850

The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

Recruiting
PHASE2Ages 7–21InterventionalTreatment
Children's Hospital Los Angeles
~10 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Butyrate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants that experience pediatric ulcerative colitis activity index score <10.
Measured over 12 weeks
Ulcerative Colitis
1 sites across 1 states
California1
  • Sonia Michail, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Los Angeles

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Eligibility criteria

Inclusion

7-21 years, mild to moderate ulcerative colitis

Exclusion

UC therapy within 4 weeks of study medication initiation
infectious colitis, -pregnancy
  • Number of participants that experience pediatric ulcerative colitis activity index score <10.12 weeks

    pediatric ulcerative colitis activity index, remission is \<10, mild disease 10-34, moderate 35-64, severe 65 or greater