Recruiting
Phase 2

Butyrate Therapy

Sponsor:

Children's Hospital Los Angeles

Code:

NCT05218850

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

Interventions

Butyrate

Study Details

Brief 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.

Conditions

Ulcerative Colitis

Study ID

NCT05218850

Start date

Jun 29, 2022

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: open label intervention arm

Butyrate enemas will be administered once daily for twelve weeks.

Interventions

Butyrate

Butyrate enemas will be administered once a day for 12 weeks

Primary outcome measure

  • Number of participants that experience pediatric ulcerative colitis activity index score <10. [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Sonia Michail, MD

3233611353sonia.michail@hotmail.com

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Sonia Michail, MD

(323) 361-1353sonia.michail@hotmail.com

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • ulcerative colitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2026-06-04.