Seaweed mineral supplement may stop pouchitis in its tracks
NCT ID NCT07501078
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 5 times
Summary
This study tests whether Aquamin, a natural mineral supplement from seaweed, can prevent pouchitis—a painful inflammation of the J-pouch—in people with ulcerative colitis who have had their colon removed. About 52 participants will take Aquamin or a placebo for up to 8 months. The goal is to see if the supplement can reduce inflammation and protect the gut lining, offering a simple way to improve long-term health.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
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 80 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: * 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 nine months * For pre-menopausal women 18 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 doses of warfarin or heparin * Participants will be excluded if they have used any of the following within the past 30 days or are unwilling to withdraw for 30 days prior to entering into the study: * Calcium, Magnesium, including multivitamins that have low amounts of Calcium/Magnesium and fiber supplements. (Multivitamins without any minerals are allowed). * Non-steroidal anti-inflammatory medications (NSAIDs), such as Naproxen or Ibuprofen (except for occasional pain control or low dose aspirin for cardiovascular disease prevention) per protocol. * Oral or rectal Corticosteroids (a type of steroid drug such as prednisone or cortisol that helps the body to regulate stress response, immune response and inflammation) and antibiotics (except these can be used briefly during a flare-up once the study treatment has begun after the subject enrolled, if prescribed by the personal physician). Inhaled and skin corticosteroids preparations are ok and not an exclusion criteria.
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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
1 site. 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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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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Other studies related to the condition(s) this trial covers.
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