The Use of Butyrate Therapy in Pediatric Ulcerative Colitis
- Registration Number
- NCT05218850
- Lead Sponsor
- Children's Hospital Los Angeles
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 7-21 years, mild to moderate ulcerative colitis
- UC therapy within 4 weeks of study medication initiation
- infectious colitis, -pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description open label intervention arm Butyrate Butyrate enemas will be administered once daily for twelve weeks.
- Primary Outcome Measures
Name Time Method remission of clinical disease 12 weeks pediatric ulcerative colitis activity index, remission is \<10, mild disease 10-34, moderate 35-64, severe 65 or greater
- Secondary Outcome Measures
Name Time Method improvement of inflammatory markers including ESR, CRP, Calprotectin 12 weeks normalization or at least improvement of inflammatory markers described above
Trial Locations
- Locations (1)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States