The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

NCT ID: NCT05218850

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2027-06-30

Brief Summary

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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

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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

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open label intervention arm

Butyrate enemas will be administered once daily for twelve weeks.

Group Type EXPERIMENTAL

Butyrate

Intervention Type DRUG

Butyrate enemas will be administered once a day for 12 weeks

Interventions

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Butyrate

Butyrate enemas will be administered once a day for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Butyrate enemas

Eligibility Criteria

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Inclusion Criteria

* 7-21 years, mild to moderate ulcerative colitis

Exclusion Criteria

* UC therapy within 4 weeks of study medication initiation
* infectious colitis, -pregnancy
Minimum Eligible Age

7 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Sonia Michail, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sonia Michail, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sonia Michail, MD

Role: CONTACT

3233611353

Facility Contacts

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Sonia Michail, MD

Role: primary

323-361-1353

Other Identifiers

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161396

Identifier Type: OTHER

Identifier Source: secondary_id

CHLA-22-00049

Identifier Type: -

Identifier Source: org_study_id

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