Using rifaximin to prevent recurrent pouchitis after surgery
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
This study is testing if taking rifaximin daily for a year can help prevent pouchitis from coming back in people who have had surgery for ulcerative colitis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06312683 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of rifaximin, an antibiotic, in preventing recurrent pouchitis in patients who have undergone surgery for ulcerative colitis. Participants aged 18 to 75, with a history of ulcerative colitis and an initial episode of pouchitis, will take rifaximin daily for one year following their treatment for pouchitis. The study aims to assess both the willingness of patients to adhere to this treatment and any unexpected side effects that may arise. The findings could lead to improved prevention strategies for recurrent pouchitis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a history of ulcerative colitis and an initial episode of pouchitis within the past year.
Not a fit: Patients with known hypersensitivity to rifaximin, Crohn's disease, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment option for patients at risk of recurrent pouchitis.
How similar studies have performed: While there is limited data on rifaximin for pouchitis specifically, similar antibiotic approaches have shown promise in managing other gastrointestinal conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New York, New York and 1 other locations
- NYU IBD Center — New York, New York, United States (Recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Edward Barnes, MD, MPH — University of North Carolina
- Study coordinator: Mikki Sandridge
- Email: mikki_sandridge@med.unc.edu
- Phone: (919) 843-3873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.