Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation (NCT07501078) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
United States52 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range5 Years – 80 Years
SexALL
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Inclusion Criteria:
* Must be able to give written informed consent (or assent as appropriate)
* Must have the following: UC with ileal pouch-anal anastomosis (IPAA) using a J-pouch without an ileostomy within the last eight months
* For pre-menopausal women 11 years of age and older with intact reproductive organs, a negative pregnancy test is required within two weeks prior to the baseline visit. Participants in this age group must agree to use an acceptable form of contraception throughout the study per protocol.
Exclusion Criteria:
* Female subjects must not be pregnant or lactating; and female of childbearing potential unwilling to use acceptable birth control throughout the study.
* Must not be participating in any other interventional trial using an investigational drug.
* Subjects likely to be uncooperative or unable to comply with study procedures
* History or diagnosis of Crohn's disease
* History or diagnosis of hereditary gastrointestinal (GI) syndromes, Severe gastrointestinal bleeding/complications, (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors).
* History or diagnosis of any gastrointestinal malignancy
* Kidney disease, including kidney "stones" or hypercalcemia. acute renal failure (past 12 weeks). (Note: A doubtful stone passed in the urine more than three years ago is not considered evidence of current renal stone disease.)
* Congenital coagulopathies or hereditary hemorrhagic disorders; treatment with therapeutic…
What they're measuring
1
Time to clinical onset of pouchitis using the Modified Pouchitis Disease Activity Index (mPDAI) clinical symptoms section