Rifaximin for the Secondary Prevention of Recurrent Pouchitis

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 with LFT's <1.5 upper limit of normal can be included)
• Severe hepatic impairment, defined as Child-Pugh Class C
• Concomitant use of p-glycoprotein (P-gp) inhibitors (e.g. cyclosporine)
• Known decreased kidney function with a glomerular filtration rate <60 ml/min/1.732
• Fecal microbiota transplantation within 16 weeks before ileostomy takedown
• History of malignancy, except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to Screening and no recurrence.
• Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. Women of child-bearing potential must have a negative urine pregnancy test prior to drug being dispensed.
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.
• Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.