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Trial intelligence / Profile preview
Butyrate Therapy in Hispanic Children With Ulcerative Colitis
NCT05218850Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2022
- Primary completion
- Jun 2027
- Countries
- 1
- Sponsor
- Children's Hospital Los Angeles
- Modality
- Small Molecules
- Drugs
- sodium butyrate
- Conditions
- ulcerative colitis (UC)
01
Overview
Phase 2, open-label, single-arm trial of sodium butyrate in ulcerative colitis (UC), sponsored by Children's Hospital Los Angeles. Primary endpoint: Pediatric Ulcerative Colitis Activity Index score < 10 at 12 weeks. Started Jun 2022; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
open label intervention arm
Butyrate enemas will be administered once daily for twelve weeks.
03
Who it enrols
Hispanic children and young adults aged 7-21 with mild to moderate ulcerative colitis, excluding those who received UC therapy within 4 weeks, have infectious colitis, or are pregnant.
04
Endpoints
Primary
Pediatric Ulcerative Colitis Activity Index score < 10
Secondary
Improvement to inflammatory markers using ESR, CRP, and Calprotectin
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