Using rifaximin to prevent recurrent pouchitis after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of rifaximin, an antibiotic, in preventing recurrent pouchitis in patients who have undergone surgery for ulcerative colitis. Participants aged 18 to 75, with a history of ulcerative colitis and an initial episode of pouchitis, will take rifaximin daily for one year following their treatment for pouchitis. The study aims to assess both the willingness of patients to adhere to this treatment and any unexpected side effects that may arise. The findings could lead to improved prevention strategies for recurrent pouchitis.

Why it matters

Who can join: the full rules

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 OR Current episode of pouchitis, but having not experienced more than 2 episodes of pouchitis in the last 12 months prior to enrollment

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.

Where it's running

• NYU IBD Center
  New York, New York, United States Recruiting
• University of North Carolina
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Edward Barnes, MD, MPH — University of North Carolina
• Study coordinator: Mikki Sandridge
• Email: mikki_sandridge@med.unc.edu
• Phone: (919) 843-3873

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Etrasimod to Help Prevent Pouchitis After Pouch Surgery

  This study tests whether etrasimod, taken daily, can help prevent pouchitis in adults who had total proctocolectomy with ileal-pouch anal anastomosis for ulcerative colitis and are currently in remission.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07486921

• Guselkumab and diet for chronic or relapsing pouchitis

  This project will test whether the drug guselkumab plus a high-fruit, low ultra-processed-food diet helps adults with chronic or relapsing pouchitis.

  Recruiting Phase 4 Universitaire Ziekenhuizen KU Leuven · Leuven, Vlaams-Brabant · NCT06916390

• Evaluating the safety and effectiveness of vedolizumab in children and teenagers with chronic pouchitis

  This study is testing if a medication called vedolizumab can help children and teenagers with chronic pouchitis feel better and stay healthy after bowel surgery.

  Recruiting at 14 sites Phase 3 Takeda · Leuven, Vlaams-Brabant and 13 other locations · NCT06443502

• Fecal microbiota transplant for chronic pouchitis treatment

  This study is testing whether a fecal microbiota transplant from healthy donors can help people with chronic pouchitis feel better when other treatments haven't worked.

  Recruiting Early Phase 1 Icahn School of Medicine at Mount Sinai · New York, New York · NCT05829109

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.