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NCT06312683 · ClinicalTrials.gov registry record · Phase 4

Rifaximin for the Secondary Prevention of Recurrent Pouchitis

A Phase 4 study of Pouchitis, sponsored by University of North Carolina, Chapel Hill.

Recruiting
Registry status
Phase 4
Development phase
16
Enrollment target
2
Study locations

NCT06312683 is a Phase 4 study of Pouchitis that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 16 participants, below the 24-participant average among 5 other Pouchitis trials with a reported enrollment target (33% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT06312683, a Phase 4 study of Pouchitis, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.

RECRUITING
Registry status
Phase 4
Development phase
16 participants
Enrollment target
2
Study locations

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

Pouchitis

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

FieldValue
Enrollment Target 16 participants
Start Date 2024-07-01
Est. Completion 2026-07
Phase Phase 4

Sponsor

University of North Carolina, Chapel Hill

1,109 total trials

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What the Registry Record Tells You About NCT06312683

The ClinicalTrials.gov registry entry for NCT06312683 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 24-participant average among 5 other Pouchitis trials with a reported enrollment target (33% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

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.

NCT06312683 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, North Carolina.

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.

What interventions are being tested in trial NCT06312683?

The interventions under investigation include: Rifaximin 550 MG Oral Tablet [XIFAXAN] (DRUG).

Who is sponsoring clinical trial NCT06312683?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.