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The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status

Not yet recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Butyrate

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring ulcerative colitis

Eligibility Criteria

7 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Children's Hospital Los Angeles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

open label intervention arm

Arm Description

Butyrate enemas will be administered once daily for twelve weeks.

Outcomes

Primary Outcome Measures

remission of clinical disease

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

Secondary Outcome Measures

calprotectin

fecal calprotectin

Full Information

NCT ID

NCT05218850

First Posted

January 20, 2022

Last Updated

January 31, 2022

Sponsor

Children's Hospital Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT05218850

Brief Title

The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

Official Title

Butyrate Therapy in Pediatric Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

June 30, 2027 (Anticipated)

Study Completion Date

June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

ulcerative colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

open label intervention arm

Arm Type

Experimental

Arm Description

Butyrate enemas will be administered once daily for twelve weeks.

Intervention Type

Drug

Intervention Name(s)

Butyrate

Other Intervention Name(s)

Butyrate enemas

Intervention Description

Butyrate enemas will be administered once a day for 12 weeks

Primary Outcome Measure Information:

Title

remission of clinical disease

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

calprotectin

Description

fecal calprotectin

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 7-21 years, mild to moderate ulcerative colitis Exclusion Criteria: UC therapy within 4 weeks of study medication initiation infectious colitis, -pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sonia Michail, MD

Phone

3233611353

sonia.michail@hotmail.com

Facility Information:

Facility Name

Children's Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

data can be shared upon request

Learn more about this trial

The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

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