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Rifaximin for the Secondary Prevention of Recurrent Pouchitis

NCT06312683 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-07-11

No results posted yet for this study

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

DRUG

Rifaximin 550 MG Oral Tablet [XIFAXAN]

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

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Edward Barnes, MD, MPH · University of North Carolina

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06312683 on ClinicalTrials.gov