The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Butyrate Therapy in Hispanic Children With Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218850
• Other study ID #: CHLA-22-00049
• Secondary ID: 161396
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

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