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Rifaximin for the Secondary Prevention of Recurrent Pouchitis
NCT06312683 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Rifaximin 550 MG Oral Tablet [XIFAXAN]
Study Locations (2)
New York
- NYU IBD Center — New York
North Carolina
- University of North Carolina — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2026-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06312683
The ClinicalTrials.gov registry entry for NCT06312683 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 725 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pouchitis appearing as the primary indexed condition, and to 1 intervention — of which Rifaximin 550 MG Oral Tablet [XIFAXAN] is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06312683 reports 2 study locations spanning 2 distinct geographic areas — top geographies include New York, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06312683 about?
NCT06312683 is a clinical study titled "Rifaximin for the Secondary Prevention of Recurrent Pouchitis". 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 e...
What is the current status of trial NCT06312683?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2024-07-01. Estimated completion is 2026-07.
What conditions does trial NCT06312683 study?
This clinical trial studies the following conditions: Pouchitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06312683?
The interventions under investigation include: Rifaximin 550 MG Oral Tablet [XIFAXAN] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06312683?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 725 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06312683 being conducted?
This trial has 2 study locations across New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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