The Use of Butyrate Therapy in Pediatric Ulcerative Colitis
Phase 2 · Testing Butyrate · 1 site · Children's Hospital Los Angeles
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Butyrate (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 7 to 21
- Any sex
Some of the main requirements, copied from the record:
- 7-21 years, mild to moderate ulcerative colitis
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 10 participants are expected to take part.
- Start date: 2022-06-29.
- Main results expected around 2027-06-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Number of participants that experience pediatric ulcerative colitis activity index score <10. (12 weeks)
In the researchers’ words
Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Children's Hospital Los Angeles |
| Enrollment | 10 (estimated) |
| Start date | 2022-06-29 |
| Primary completion (est.) | 2027-06-30 |
| First posted | 2022-02-01 |
| Last updated | 2026-06-04 |
| Official title | Butyrate Therapy in Hispanic Children With Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT05218850 |
Interventions
- Butyrate (Drug)
Butyrate enemas will be administered once a day for 12 weeks
Full eligibility criteria (from the record)
Inclusion Criteria: * 7-21 years, mild to moderate ulcerative colitis Exclusion Criteria: * UC therapy within 4 weeks of study medication initiation * infectious colitis, -pregnancy
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.