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Prevention study for Pouchitis
Official title Rifaximin for the Secondary Prevention of Recurrent Pouchitis
ClinicalTrials.gov ID: NCT06312683
What this study is testing
What is Rifaximin 550 MG Oral Tablet [XIFAXAN]?
Rifaximin 550 MG Oral Tablet [XIFAXAN] is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pouchitis.
Also referred to as Xifaxan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- 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...
- Diagnosis of initial episode of pouchitis within the first 12 months after ileostomy takedown/final stage of IPAA surgery
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.