Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Minor Start date pushed from Sep 2026 to Oct 2026 Show 4 more changesShow less
    • Primary and study completion dates: Jun 2029 to Jul 2029
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Collaborators: details revised at 1 of 1 entry
  2. Minor Primary and study completion dates: May 2029 to Jun 2029
    • Start date: Aug 2026 to Sep 2026
    v5
  3. Minor Start date: Jul 2026 to Aug 2026
    • Eligibility criteria revised
    v4
  4. Notable Recruitment opened
    • Start date: Jun 2026 to Jul 2026
    • Site details revised
    v3
  5. Minor Start date: May 2026 to Jun 2026v2
  6. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ulcerative colitis (UC) is a disease that causes long-term inflammation in the digestive tract, and many people with this condition require surgery to remove the colon and create a new J-pouch for stool. Some patients develop a problem called pouchitis, where this pouch becomes inflamed. Current treatments are limited, and there are no known ways to prevent pouchitis from starting. This study is being done to find out if a natural mineral supplement called Aquamin® can help reduce inflammation and protect the gut lining in people with a J-pouch, and may reduce the risk of pouchitis. By understanding whether Aquamin® is safe and helpful, the study team hopes to find a new and better way to prevent inflammation and improve the long-term health of people with UC.
Trial Details
NCT Number NCT07501078
Lead Sponsor Muhammad N Aslam, MD
Collaborators: Crohn's and Colitis Foundation
Conditions
(from sponsor)
Ulcerative Colitis, Ileal Pouch
Related terms Colitis, Ulcerative
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov