Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Part of paid clinical trials in New York, New York.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06312683
Phase
PHASE4
Status
Recruiting
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Conditions

  • Pouchitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Rifaximin 550 MG Oral Tablet [XIFAXAN] — DRUG
    Rifaximin 550 MG Oral Tablet \[XIFAXAN\] Taken twice a day for up to 365 days

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: All Participants
    550 mg Rifaximin (Xifaxan) twice a day x 365 days

Primary Outcome Measure

Percentage of Participants Who Develop Recurrent Pouchitis [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NYU IBD CenterNew YorkNew York10016
Nathasha Melukkaran
[email protected]
646-754-3417
Shannon Chang, MD, MBA (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27599
Mikki Sandridge
[email protected]
919-843-3873
Edward Barnes, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
NYU IBD Center· New York, NYUniversity of North Carolina· Chapel Hill, NC

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