Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Mar 8, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether an antibiotic called rifaximin can help prevent pouchitis from coming back after someone has had an initial episode. Pouchitis is inflammation of the pouch that is created after surgery for ulcerative colitis. Many people experience this condition multiple times, and currently, there aren't effective treatments to stop it from recurring. In this study, participants will take rifaximin daily for one year after being treated for their first episode of pouchitis. The researchers want to see if people are willing to take this medication for a year and if they experience any unexpected side effects.

To be eligible for the trial, participants must be between 18 and 75 years old and have a history of ulcerative colitis along with having had surgery to create a pouch. They should have been diagnosed with their first episode of pouchitis within the last year. However, certain conditions would exclude someone from participating, such as being allergic to rifaximin, having Crohn's disease, or experiencing severe liver or kidney problems. If you join the study, you’ll be monitored closely, and the information gathered will help improve treatment options for preventing pouchitis in the future.

Gender

ALL

Eligibility criteria

• 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.