UCRecruiting
Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
Phase 2 · Testing Aquamin · 1 site · Muhammad N Aslam, MD
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Aquamin (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis and Ileal Pouch.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 52 participants are expected to take part.
- The study has 2 groups.
- Start date: 2026-10 (planned).
- Main results expected around 2029-07 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Aquamin (listed as: experimental group)
- Placebo (listed as: placebo group)
Main thing being measured
- Time to clinical onset of pouchitis using the Modified Pouchitis Disease Activity Index (mPDAI) clinical symptoms section (Baseline up to day 365)
In the researchers’ words
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.
Words you might see
- Placebo: a look-alike pill or injection with no active drug, used for comparison.
- Ileal pouch (IPAA): an internal pouch made from the small intestine after the colon is removed; pouchitis is inflammation of it.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis; Ileal Pouch |
| Lead sponsor | Muhammad N Aslam, MD |
| Collaborators | Crohn's and Colitis Foundation |
| Enrollment | 52 (estimated) |
| Start date | 2026-10 |
| Primary completion (est.) | 2029-07 |
| First posted | 2026-03-30 |
| Last updated | 2026-10-02 |
| Official title | Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation |
| ClinicalTrials.gov ID | NCT07501078 |
Interventions
- Aquamin (Drug)
Participants will take 2400 milligrams of Aquamin (containing approximately 800 milligrams calcium/day) per day (2 capsules in the morning, two capsules in the evening, or all 4 at one time), oral administration, for 365 days. If participants cannot swallow capsule whole, the capsule may be opened and mixed into liquid or soft food (e.g., water or applesauce) to be consumed. Participants will als… - Placebo (Drug)
Participants will take 4 capsules per day; 2 to be taken in the morning and 2 in the evening or all 4 at once. Participants will take this for 365 days. If participants cannot swallow capsule whole, the capsule may be opened and mixed into liquid or soft food (e.g., water or applesauce) to be consumed. Participants will also take lactulose and mannitol on days day 0, day 180, and day 365 to measu…
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan | Ann Arbor, Michigan | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.