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NCT Number: NCT05218850

The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

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.

Recruiting

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

7 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location status: Recruiting

Location contact

Sonia Michail, MD

CONTACT

[email protected]

(323) 361-1353

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 7-21 years, mild to moderate ulcerative colitis

Exclusion criteria

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

Treatment and study plan

Butyrate

Drug

Butyrate enemas will be administered once a day for 12 weeks

Other names: Butyrate enemas

Primary outcomes

  1. Number of participants that experience pediatric ulcerative colitis activity index score <10.

    Time frame: 12 weeks

    pediatric ulcerative colitis activity index, remission is <10, mild disease 10-34, moderate 35-64, severe 65 or greater

Secondary outcomes

  1. Number of participants with improvement to inflammatory markers using ESR, CRP, and Calprotectin

    Time frame: 12 weeks

    normalization or at least improvement of inflammatory markers described above

Study contacts

Contact information is provided by the study sponsor or research team.

Sonia Michail, MD

CONTACT

[email protected]

3233611353

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study title

Butyrate Therapy in Hispanic Children With Ulcerative Colitis

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 1, 2022
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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