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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05218850
Other study ID # CHLA-22-00049
Secondary ID 161396
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 29, 2022
Est. completion date June 30, 2027

Study information

Verified date April 2024
Source Children's Hospital Los Angeles
Contact Sonia Michail, MD
Phone 3233611353
Email sonia.michail@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 30, 2027
Est. primary completion date June 30, 2027
Accepts healthy volunteers No
Gender All
Age group 7 Years to 21 Years
Eligibility Inclusion Criteria: - 7-21 years, mild to moderate ulcerative colitis Exclusion Criteria: - UC therapy within 4 weeks of study medication initiation - infectious colitis, -pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Butyrate
Butyrate enemas will be administered once a day for 12 weeks

Locations

Country Name City State
United States Children's Hospital Los Angeles Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 improvement of inflammatory markers including ESR, CRP, Calprotectin normalization or at least improvement of inflammatory markers described above 12 weeks
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