Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312683
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-03-08
Brief Title:
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Although many people will develop recurrent pouchitis inflammation of the ileal pouch-anal anastomosis or J-pouch after colectomy for ulcerative colitis after an initial episode of pouchitis there are currently no effective treatments to prevent recurrent pouchitis The goal of this study is to evaluate the potential for rifaximin an antibiotic to prevent recurrent pouchitis after treatment for an initial episode of pouchitis In this study all patients will be given daily rifaximin for one year after being treated for an initial episode of pouchitis This study will examine whether people are willing to take rifaximin for one year with the goal of preventing recurrent pouchitis Additionally this study will examine whether patients experience any unexpected side effects of rifaximin therapy The information gained through this study will potentially be helpful in improving the ability to prevent recurrent pouchitis in patients who have a colectomy for ulcerative colitis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None