Rifaximin for the Secondary Prevention of Recurrent Pouchitis

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.