Rifaximin for the Secondary Prevention of Recurrent Pouchitis
Trial Parameters
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Known hypersensitivity to rifaximin or its metabolites * Known Crohn's disease * History of perianal fistula * Known incontinence due to anal sphincter dysfunction * Known irritable pouch syndrome * Active ongoing pelvic infection/sepsis at baseline visit * New onset of high bowel frequency in the setting of acute pouchitis in the first 4 weeks after IPAA * Known Clostridoides difficile infection * Need for antibiotic long-term therapy (e.g. doxycycline for acne) * Known active Hepatitis B, C, HIV * Clinically significant liver disease (Primary Sclerosing Cholangitis