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Seaweed mineral supplement may stop pouchitis in its tracks

NCT ID NCT07501078

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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