NCT06312683 · University of North Carolina, Chapel Hill
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
What this study 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.
View original scientific description
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.
Interventions
DRUG
Rifaximin 550 MG Oral Tablet [XIFAXAN]
Rifaximin 550 MG Oral Tablet \[XIFAXAN\] Taken twice a day for up to 365 days
Primary outcome measures
Percentage of Participants Who Develop Recurrent Pouchitis
Time frame: 12 months
Recurrent pouchitis, defined as a second episode of pouchitis within a 12 month period after the initial episode of pouchitis or the need for prolonged/recurrent antibiotics after the initial 14 day period (and initiation of rifaximin).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 Cholangit
Where
- New York, New York
- Chapel Hill, North Carolina
Collaborators
Bausch Health Americas, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 11, 2025 · Source of record for eligibility and locations