The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

Last updated: April 17, 2024
Sponsor: Children's Hospital Los Angeles
Overall Status: Active - Recruiting

Phase

1

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Ulcers

Treatment

Butyrate

Clinical Study ID

NCT05218850
CHLA-22-00049
161396
  • Ages 7-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 7-21 years, mild to moderate ulcerative colitis

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Butyrate
Phase: 1
Study Start date:
June 29, 2022
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

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