The Use of Butyrate Therapy in Pediatric Ulcerative Colitis
Butyrate Therapy in Hispanic Children With Ulcerative Colitis
2 other identifiers
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2022
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2022
CompletedFirst Posted
Study publicly available on registry
February 1, 2022
CompletedStudy Start
First participant enrolled
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
April 18, 2024
April 1, 2024
5 years
January 20, 2022
April 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
remission of clinical disease
pediatric ulcerative colitis activity index, remission is \<10, mild disease 10-34, moderate 35-64, severe 65 or greater
12 weeks
Secondary Outcomes (1)
improvement of inflammatory markers including ESR, CRP, Calprotectin
12 weeks
Study Arms (1)
open label intervention arm
EXPERIMENTALButyrate enemas will be administered once daily for twelve weeks.
Interventions
Butyrate enemas will be administered once a day for 12 weeks
Eligibility Criteria
You may qualify if:
- years, mild to moderate ulcerative colitis
You may not qualify if:
- UC therapy within 4 weeks of study medication initiation
- infectious colitis, -pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sonia Michail, MD
Children's Hospital Los Angeles
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 20, 2022
First Posted
February 1, 2022
Study Start
June 29, 2022
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
April 18, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
data can be shared upon request