Rifaximin for the Secondary Prevention of Recurrent Pouchitis

NCT06312683 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 23-2111
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pouchitis

Keywords

Recurrent pouchitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Develop Recurrent Pouchitis

  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).

  12 months

Study Arms (1)

All Participants

EXPERIMENTAL

550 mg Rifaximin (Xifaxan) twice a day x 365 days

Drug: Rifaximin 550 MG Oral Tablet [XIFAXAN]

Interventions

Rifaximin 550 MG Oral Tablet [XIFAXAN] DRUG

Rifaximin 550 MG Oral Tablet \[XIFAXAN\] Taken twice a day for up to 365 days

Also known as: Xifaxan

All Participants

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (2)

NYU IBD Center

New York, New York, 10016, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Publications (101)

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MeSH Terms

Conditions

Pouchitis

Interventions

Rifaximin; Tablets

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Edward Barnes, MD, MPH

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikki Sandridge

CONTACT

(919) 843-3873; mikki_sandridge@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: beginning 9 and continuing for 12 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (2)