The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

Children's Hospital Los Angeles

Status and phase: Enrolling; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: Butyrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05218850

CHLA-22-00049

161396 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 7 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 7-21 years, mild to moderate ulcerative colitis

Exclusion criteria

• UC therapy within 4 weeks of study medication initiation
• infectious colitis, -pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

open label intervention arm

Experimental group

Description:

Butyrate enemas will be administered once daily for twelve weeks.

Treatment:

Drug: Butyrate