Phase
Condition
N/ATreatment
Rifaximin 550 MG Oral Tablet [XIFAXAN]
Clinical Study ID
Ages 18-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ileostomytakedown/final stage of IPAA surgery
Exclusion
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 4weeks 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 <1.5upper 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 cellcarcinoma 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 theInvestigator from local testing.
Female who is pregnant, breast-feeding or intends to become pregnant or is ofchild-bearing potential and not using a highly effective contraceptive method. Womenof child-bearing potential must have a negative urine pregnancy test prior to drugbeing dispensed.
Participation in any clinical trial of an approved or non-approved investigationalmedicinal product within 30 days before screening.
Any disorder, which in the investigator's opinion might jeopardize participant'ssafety or compliance with the protocol.
Study Design
Connect with a study center
NYU IBD Center
New York, New York 10016
United StatesActive - Recruiting
University of North Carolina
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting

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