Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
New York
NYU IBD Center
RECRUITING
New York
Contact Information
Primary
Mikki Sandridge
mikki_sandridge@med.unc.edu
(919) 843-3873
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 16
Treatments
Experimental: All Participants
550 mg Rifaximin (Xifaxan) twice a day x 365 days
Sponsors
Collaborators: Bausch Health Americas, Inc.
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov

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