NCT06312683

Rifaximin for the Secondary Prevention of Recurrent Pouchitis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pouchitis

Interventions

Type	Name	Description
DRUG	Rifaximin 550 MG Oral Tablet [XIFAXAN]	Rifaximin 550 MG Oral Tablet \[XIFAXAN\] Taken twice a day for up to 365 days

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-03-15
• Last updated: 2025-07-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study