About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent will be obtained before any study-related procedures
Age > 18 and <75 years
Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage Ileal pouch anal anastomosis (IPAA) and ileostomy takedown
Diagnosis of initial episode of pouchitis within the first 12 months after ileostomy takedown/final stage of IPAA surgery
Disqualifiers
Known hypersensitivity to rifaximin or its metabolites
Known Crohn's disease
History of perianal fistula
Known incontinence due to anal sphincter dysfunction
Trial design
Single group
Treatments tested in this trial
Rifaximin 550 MG Oral Tablet [XIFAXAN]
DrugRifaximin 550 MG Oral Tablet \[XIFAXAN\] Taken twice a day for up to 365 days
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Participants Who Develop Recurrent Pouchitis
Recurrent pouchitis, defined as a second episode of pouchitis within a 12 month period after the initial episode of pouchitis or the need for prolonged/recurrent antibiotics after the initial 14 day period (and initiation of rifaximin).
Sponsors and contacts
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University of North Carolina, Chapel Hill
Lead sponsor
Bausch Health Americas, Inc.
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator