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Aquamin® for Preventing Pouchitis in Ulcerative Colitis

This study is investigating if a natural mineral supplement called Aquamin® can help prevent inflammation in people who have had surgery for ulcerative colitis (UC). UC is a disease causing inflammation in the digestive tract, and many patients have surgery to remove their colon and create a J-pouch. Sometimes, this J-pouch can become inflamed, a condition called pouchitis. Current treatments for pouchitis are limited, and there's no known way to prevent it. This study will give participants either Aquamin® or a placebo (an inactive substance) for a year to see if Aquamin® can reduce inflammation and protect the gut lining, potentially lowering the risk of pouchitis. We are looking for 52 participants, aged 5 to 80, who have UC and a J-pouch created within the last eight months.

Study design
This is an interventional study comparing Aquamin® to a placebo. It plans to enroll 52 participants.
What's involved
Participants will take 4 capsules of either Aquamin® or a placebo daily for 365 days. Capsules can be taken whole or opened and mixed into liquid or soft food.
Compensation
Not stated in the trial record.
Follow-up
The study will track the time to clinical onset of pouchitis for up to 365 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07501078

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

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Muhammad N Aslam, MD
~52 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:AquaminPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to clinical onset of pouchitis using the Modified Pouchitis Disease Activity Index (mPDAI) clinical symptoms section
Measured over Baseline up to day 365

Conditions

Ulcerative Colitis
Ileal Pouch

Explore related trials

Ileal pouchUlcerative Colitis

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Muhammad N Aslam, MBBS, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Lauren Manning
[email protected]
734-615-7236
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Time to clinical onset of pouchitis using the Modified Pouchitis Disease Activity Index (mPDAI) clinical symptoms sectionBaseline up to day 365

    The Modified Pouchitis Disease Activity Index was developed for diagnosing active pouchitis and quantifying the severity of pouchitis. The index includes the clinical criteria of 1) stool frequency 2) rectal bleeding 3) Fecal Urgency/Abdominal Cramps and 4) presence or absence of fever. Scores range from 0-6 (without endoscopic measures). The higher the score, the worse the disease activity.