Ulcerative ColitisPhase 2NCT07501078
Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
A Phase 2 study testing Aquamin in people with Ulcerative Colitis and Ileal Pouch, run by Muhammad N Aslam, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis, Ileal Pouch
- What is being tested?
- Aquamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Lauren Manning, 734-615-7236, lbadish@med.umich.edu
Muhammad N Aslam, MBBS, MD
About this study
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.
- Conditions
- Ulcerative Colitis, Ileal Pouch
- Being tested
- Aquamin
- Keywords
- J-pouch without an ileostomy, Surveys, Sample collection, Placebo, Aquamin®, Randomization
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquaminDrug
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 up to 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 measure the lactulose:mannitol ratio to assess gastrointestinal permeability.
| Study group | Role | What they receive |
|---|---|---|
| Aquamin | Experimental | Not described Receives: Drug: Aquamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Intestinal permeability assessed by urinary Lactulose/mannitol urinary ratio
Lactulose/mannitol excretion after oral load.
Measured: Baseline, Approximately Days 180 and 365
Secondary outcomes (3)
Changes in Serum C-reactive protein (CRP) as marker of inflammation
Blood samples will be drawn for C-reactive protein (CRP) levels.
Measured: Baseline, Approximately Days 180 and 365
Changes in Fecal calprotectin (FCAL) as marker of inflammation
Measured: Baseline, Approximately Days 180 and 365
Time to clinical onset of pouchitis using the Modified Pouchitis Disease Activity Index (mPDAI) clinical symptoms section
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.
Measured: Baseline up to day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad N Aslam, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Sponsor-investigator, Muhammad N Aslam, MD, University of Michigan
- Investigators
- Muhammad N Aslam, MBBS, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501078
- Sponsor's protocol ID
- HUM00284005
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
- ClinicalTrials.gov ID
- NCT07501078
- Acronym / sponsor ID
- HUM00284005
- Conditions
- Ulcerative Colitis, Ileal Pouch
- Keywords
- J-pouch without an ileostomy, Surveys, Sample collection, Placebo, Aquamin®, Randomization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Muhammad N Aslam, MDUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquamin | Experimental | Drug: Aquamin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AquaminParticipants 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 up to 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 measure the lactulose:mannitol ratio to assess gastrointestinal permeability. | Drug | Aquamin |
Primary outcome
Changes in Intestinal permeability assessed by urinary Lactulose/mannitol urinary ratio
Time frame: Baseline, Approximately Days 180 and 365
Lactulose/mannitol excretion after oral load.
3 secondary outcomes
Changes in Serum C-reactive protein (CRP) as marker of inflammation
Time frame: Baseline, Approximately Days 180 and 365
Changes in Fecal calprotectin (FCAL) as marker of inflammation
Time frame: Baseline, Approximately Days 180 and 365
Time to clinical onset of pouchitis using the Modified Pouchitis Disease Activity Index (mPDAI) clinical symptoms section
Time frame: Baseline up to day 365
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad N Aslam, MBBS, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aquamin in people with Ulcerative Colitis and Ileal Pouch, run by Muhammad N Aslam, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Manning (734-615-7236, lbadish@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Intestinal permeability assessed by urinary Lactulose/mannitol urinary ratio (time frame: Baseline, Approximately Days 180 and 365). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.