Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Pouchitis Clinical Trial

Official title:

Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06312683
• Other study ID #: 23-2111
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Mikki Sandridge
• Phone: (919) 843-3873
• Email: mikki_sandridge[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pouchitis

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (101)

Administration FaD. Rifaximin

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* Note: There are 101 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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