The Use of Butyrate Therapy in Pediatric Ulcerative Colitis | NCT05218850

Studies
The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

NCT05218850

Sponsor

Children's Hospital Los Angeles

Status

Recruiting

Last Update Posted

Jun 4, 2026Actual

Enrollment

10Estimated

Phase

Phase 2

Conditions

Ulcerative Colitis

Interventions

Butyrate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
161396	Other Identifier	IND

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2022Actual

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Jan 20, 2022

First Submission Date that Met QC Criteria

Jan 20, 2022

First Posted Date

Feb 1, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2026

Last Update Posted Date

Jun 4, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sonia Michail, MD, Principal Investigator, Children's Hospital Los AngelesPrincipal Investigator

Lead Sponsor

Children's Hospital Los AngelesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
open label intervention arm	Experimental	Butyrate enemas will be administered once daily for twelve weeks.	Drug: Butyrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Butyrate	Drug	Butyrate enemas will be administered once a day for 12 weeks	open label intervention arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants that experience pediatric ulcerative colitis activity index score <10.	pediatric ulcerative colitis activity index, remission is <10, mild disease 10-34, moderate 35-64, severe 65 or greater	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with improvement to inflammatory markers using ESR, CRP, and Calprotectin	normalization or at least improvement of inflammatory markers described above	12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sonia Michail, MD	Contact	3233611353		sonia.michail@hotmail.com

Overall Officials

Name	Affiliation	Role
Sonia Michail, MD	Children's Hospital Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Los Angeles	Recruiting	Los Angeles	California	90027	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

data can be shared upon request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002087	Butyrates

Ancestor Terms

ID	Term
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005232	Fatty Acids, Volatile

Browse Leaves

Not provided

Browse Branches

Not provided