Rifaximin for the Secondary Prevention of Recurrent Pouchitis

ConditionPouchitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-74
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known hypersensitivity to rifaximin or its metabolites

Known Crohn's disease

History of perianal fistula

Known incontinence due to anal sphincter dysfunction

Trial design

Design model

Single group

Treatments tested in this trial

  • Rifaximin 550 MG Oral Tablet [XIFAXAN]

    Drug

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

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: All ParticipantsExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

Bausch Health Americas, Inc.

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator