The Use of Butyrate Therapy in Pediatric Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Butyrate.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: 7 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Butyrate Therapy in Hispanic Children With Ulcerative Colitis
Overview
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.
Detailed description
butyrate enemas will be administered for 12 weeks to children ages 7 to 21 with mild to moderate ulcerative colitis to determine if butyrate therapy can help improve the clinical disease in those children. standard management of the disease will be performed during these 12 weeks including routine laboratory studies and endoscopy.
Interventions
- Drug Butyrate
Butyrate enemas will be administered once a day for 12 weeks
Primary outcome measures
- Number of participants that experience pediatric ulcerative colitis activity index score <10. [Time frame: 12 weeks]
Secondary outcome measures (1)
- Number of participants with improvement to inflammatory markers using ESR, CRP, and Calprotectin [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 7-21 years, mild to moderate ulcerative colitis
Exclusion criteria
- UC therapy within 4 weeks of study medication initiation
- infectious colitis, -pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children's Hospital Los Angeles — Los Angeles
Identifiers
NCT: NCT05218850 · CHLA-22-00049 · 161396