Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Last updated: July 8, 2025
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Rifaximin 550 MG Oral Tablet [XIFAXAN]

Clinical Study ID

NCT06312683
23-2111
  • Ages 18-74
  • All Genders

Study Summary

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.

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

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: Rifaximin 550 MG Oral Tablet [XIFAXAN]
Phase: 4
Study Start date:
July 01, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • NYU IBD Center

    New York, New York 10016
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

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