The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT05218850
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
7 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Butyrate — DRUG
    Butyrate enemas will be administered once a day for 12 weeks

Study Details

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.

Key Dates

Start date
Jun 29, 2022
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: open label intervention arm
    Butyrate enemas will be administered once daily for twelve weeks.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Sonia Michail, MD
[email protected]
(323) 361-1353

Find similar trials in Los Angeles, CA

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Children's Hospital Los Angeles· Los Angeles, CA

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