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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
232 Previous Clinical Trials
5,076,758 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
101 Patients Enrolled for Ulcerative Colitis
Sonia Michail, MDPrincipal InvestigatorChildren's Hospital Los Angeles
5 Previous Clinical Trials
144 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
101 Patients Enrolled for Ulcerative Colitis

Media Library

Butyrate (Short Chain Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT05218850 — Phase 1
Ulcerative Colitis Research Study Groups: open label intervention arm
Ulcerative 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any recent openings in this medical study for participants?

"This research endeavour, which was initially publicized on July 1st 2022 and most recently edited on January 31st 2022, is not presently in pursuit of applicants. Nevertheless, 408 other studies are actively recruiting candidates at this moment."

Answered by AI

Could I fulfill the conditions necessary to participate in this clinical experiment?

"For this experiment, 10 minors between the ages of 7 and 21 with mild to moderate ulcerative colitis are needed."

Answered by AI

Does this trial accept individuals aged above 20?

"This clinical study is searching for participants who are between the ages of 7 and 21."

Answered by AI

What hazards may be associated with taking Butyrate?

"The safety of Butyrate is rated as 1, as this trial has only collected minimal data about its efficacy and security."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Use of Butyrate Therapy in Pediatric Ulcerative Colitis
Sonia Michail, MD 2022. "The Use of Butyrate Therapy in Pediatric Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05218850.
All > Ulcerative Colitis > Colitis
~6 spots leftby Jun 2027
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