Can a common antibiotic stop pouchitis from coming back?
NCT ID NCT06312683
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This trial tests whether taking the antibiotic rifaximin daily for a year can prevent recurrent pouchitis—inflammation of the J-pouch—after an initial episode in people who had surgery for ulcerative colitis. All participants will receive rifaximin twice a day for up to 365 days. The study will see if people are willing to take it long-term and if it reduces the chance of a second episode, while also monitoring for unexpected side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rifaximin (an antibiotic, brand name Xifaxan)
- What this could lead to
- If it works, this could point toward a way to prevent recurrent pouchitis in people who have had surgery for ulcerative colitis.
- What could go wrong
- This is a small, early-phase study with only 16 participants, so results may not apply broadly. Rifaximin may cause side effects or may not effectively prevent recurrence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYU IBD Center
RECRUITINGNew York, New York, 10016, United States
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University of North Carolina
RECRUITINGChapel Hill, North Carolina, 27599, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple topical treatment stop a common Post-Surgery complication in ulcerative colitis?
- Can a stool transplant soothe an inflamed pouch?
- Sound waves vs. scope: a gentler way to spot pouch inflammation?
- Can a stool transplant calm an inflamed pouch?
- New combo tackles stubborn gut inflammation after colitis surgery
- Stem cell shot for pouchitis fails to launch