Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 7:40 PM
Study NCT ID:
NCT05218850
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2022-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Butyrate Therapy in Pediatric Ulcerative Colitis
Sponsor:
Children's Hospital Los Angeles
Organization:
Study Overview
Official Title:
Butyrate Therapy in Hispanic Children With Ulcerative Colitis
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 161396 | OTHER | IND | View |