NCT05218850

The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

Butyrate Therapy in Hispanic Children With Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 7 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Butyrate	Butyrate enemas will be administered once a day for 12 weeks

Timeline

• Start date: 2022-06-29
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2022-02-01
• Last updated: 2024-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study