Ulcerative Colitis
Conditions
Keywords
ulcerative colitis
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.
Interventions
DRUGButyrate
Butyrate enemas will be administered once a day for 12 weeks
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* 7-21 years, mild to moderate ulcerative colitis
Exclusion criteria
* UC therapy within 4 weeks of study medication initiation * infectious colitis, -pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that experience pediatric ulcerative colitis activity index score <10. | 12 weeks | pediatric ulcerative colitis activity index, remission is \<10, mild disease 10-34, moderate 35-64, severe 65 or greater |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with improvement to inflammatory markers using ESR, CRP, and Calprotectin | 12 weeks | normalization or at least improvement of inflammatory markers described above |
Countries
United States
Contacts
CONTACTSonia Michail, MD
PRINCIPAL_INVESTIGATORSonia Michail, MD
Children's Hospital Los Angeles
Outcome results
None listed