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Short Chain Fatty Acid

Butyrate Therapy for Pediatric Ulcerative Colitis

Phase 1
Recruiting
Led By Sonia Michail, MD
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 7-21 years with mild to moderate ulcerative colitis
Be younger than 65 years old
Must not have
History of infectious colitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a therapy involving butyrate, a metabolite produced by the gut microbiome, is effective in treating ulcerative colitis in children.

Who is the study for?
This trial is for children and young adults aged 7-21 with mild to moderate ulcerative colitis. Participants must not be pregnant, should not have received ulcerative colitis therapy within the last 4 weeks, and must not have infectious colitis.
What is being tested?
The study is testing butyrate enemas as a treatment for pediatric ulcerative colitis. Butyrate is a compound produced in the gut that may help manage this condition. The trial aims to assess how effective this approach could be.
What are the potential side effects?
While specific side effects are not listed, butyrate treatments might cause discomfort or irritation at the site of enema application, digestive issues like bloating or gas, and potential changes in bowel movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 7 and 21 years old with mild to moderate ulcerative colitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had infectious colitis in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
remission of clinical disease
Secondary study objectives
improvement of inflammatory markers including ESR, CRP, Calprotectin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: open label intervention armExperimental Treatment1 Intervention
Butyrate enemas will be administered once daily for twelve weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Butyric Acid
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
246 Previous Clinical Trials
5,073,332 Total Patients Enrolled
1 Trials studying Colitis
101 Patients Enrolled for Colitis
Sonia Michail, MDPrincipal InvestigatorChildren's Hospital Los Angeles
5 Previous Clinical Trials
144 Total Patients Enrolled
2 Trials studying Colitis
110 Patients Enrolled for Colitis

Media Library

Butyrate (Short Chain Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT05218850 — Phase 1
Colitis Research Study Groups: open label intervention arm
Colitis Clinical Trial 2023: Butyrate Highlights & Side Effects. Trial Name: NCT05218850 — Phase 1
Butyrate (Short Chain Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05218850 — Phase 1
~5 spots leftby Jun 2027
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