Actively Recruiting
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
Led by University of North Carolina, Chapel Hill · Updated on 2025-07-11
16
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
B
Bausch Health Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent will be obtained before any study-related procedures
- Age greater than 18 and less than 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
You will not qualify if you...
- 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 or 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 long-term antibiotic therapy (e.g., doxycycline for acne)
- Known active Hepatitis B, Hepatitis C, or HIV
- Clinically significant liver disease (Primary Sclerosing Cholangitis with liver function tests less than 1.5 times upper limit of normal can be included)
- Severe hepatic impairment, defined as Child-Pugh Class C
- Use of p-glycoprotein (P-gp) inhibitors (e.g., cyclosporine)
- Known decreased kidney function with glomerular filtration rate less than 60 ml/min/1.732
- Fecal microbiota transplantation within 16 weeks before ileostomy takedown
- History of malignancy except basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years before Screening and no recurrence
- Clinically significant laboratory results at screening or baseline as judged by the Investigator from local testing
- Female who is pregnant, breastfeeding, 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 before drug is dispensed
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening
- Any disorder which might jeopardize participant's safety or compliance with the protocol as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
NYU IBD Center
New York, New York, United States, 10016
Actively Recruiting
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
M
Mikki Sandridge
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here