Ileal Pouch · Ulcerative Colitis
Aquamin to Prevent Inflammation in Ulcerative Colitis J-Pouches
This study is investigating whether one year of Aquamin can reduce inflammation and delay pouchitis in people with ulcerative colitis who recently received a J-pouch, compared with placebo.
Registry title: Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
1 recruiting U.S. site ↓Study at a glance
- Age
- 5 Years–80 Years
- Treatment
- Aquamin or Placebo
- Design
- Randomized · Triple
- Central study contact
- Lauren Manning734-615-7236lbadish@med.umich.edu
- Sponsor
- Muhammad N Aslam, MD
Research question
Compared with placebo, does taking Aquamin for 365 days delay the clinical onset of pouchitis and affect measures of intestinal permeability and inflammation?
Participant snapshot
Who the study is looking for
- The study is looking for people ages 5 through 80.
- The study is looking for people with ulcerative colitis and an ileal pouch-anal anastomosis using a J-pouch.
- The J-pouch must be without an ileostomy and must have been created within the last eight months, according to the criterion as written.
- The registry lists one recruiting location at the University of Michigan in Ann Arbor.
Participation overview
What participation may involve
Participants take either Aquamin or placebo capsules daily for 365 days and complete symptom, intestinal-permeability, blood inflammation, and fecal inflammation assessments. What participation may involve: - Take four Aquamin or placebo capsules by mouth each day; capsules may be opened into liquid or soft food if they cannot be swallowed whole. - Take lactulose and mannitol on days 0, 180, and 365 for an intestinal-permeability assessment based on their urinary ratio. - Complete assessments of pouchitis symptoms, including stool frequency, rectal bleeding, urgency or abdominal cramps, and fever. - Provide blood for C-reactive protein testing and complete fecal calprotectin assessments at baseline and around days 180 and 365. The assigned capsules are taken for 365 days.
Study interventions
What participants may receive or do
- Aquamin: Participants assigned to Aquamin take 2,400 milligrams daily, containing about 800 milligrams of calcium, as four oral capsules for 365 days. The capsules may be divided between morning and evening or taken together.
- Placebo: Participants assigned to placebo take four maltodextrin capsules daily for 365 days, either divided between morning and evening or taken together.
Study design
How the comparison works
This is an estimated 52-person phase 2 study with parallel Aquamin and placebo groups. Participants are randomly assigned, and participants, care providers, and investigators are masked to assignment. Participants are randomly assigned to one of two parallel groups, but the registry does not report the assignment ratio. The study is triple masked: participants, care providers, and investigators are not told the assigned group. The Aquamin group is compared with a placebo group receiving maltodextrin capsules. The placebo is taken as four capsules per day for 365 days. The registry identifies maltodextrin as its other name.
Reported activities
Procedures and tests
- Clinical pouchitis symptoms are scored using the clinical section of the Modified Pouchitis Disease Activity Index.
- Participants take lactulose and mannitol, followed by measurement of their urinary ratio to assess intestinal permeability.
- Blood is drawn to measure C-reactive protein, a marker of inflammation.
- Fecal calprotectin is assessed as a marker of inflammation.
- For premenopausal participants age 11 or older with intact reproductive organs, screening requires a negative pregnancy test within two weeks before the baseline visit.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be able to provide written informed consent or assent, as appropriate.
- Participants must have ulcerative colitis with an ileal pouch-anal anastomosis using a J-pouch without an ileostomy within the last eight months.
- The registry age range is 5 through 80 years.
- Premenopausal participants age 11 or older with intact reproductive organs need a negative pregnancy test within two weeks before baseline and must agree to protocol-accepted contraception throughout the study.
Possible reasons someone may not be able to join
- People who are pregnant or lactating are excluded; those who could become pregnant must be willing to use acceptable birth control throughout the study.
- Participation in another interventional trial using an investigational drug is not allowed.
- A history or diagnosis of Crohn's disease is exclusionary.
- Hereditary gastrointestinal syndromes, severe gastrointestinal bleeding or complications, gastric or duodenal ulcer bleeding, or gastrin-secreting tumors are exclusionary.
- A history or diagnosis of any gastrointestinal cancer is exclusionary.
- Kidney disease, kidney stones, high blood calcium, or acute kidney failure within the past 12 weeks may exclude someone, with the stated exception for a doubtful stone passed more than three years ago.
- Congenital clotting or hereditary bleeding disorders, or treatment-dose warfarin or heparin, are exclusionary.
- Participants must not have used calcium, magnesium, mineral-containing multivitamins, or fiber supplements in the past 30 days and must be willing to stop them for 30 days before study entry; mineral-free multivitamins are allowed.
- Nonsteroidal anti-inflammatory drugs such as naproxen or ibuprofen must generally be stopped for 30 days before entry, except for occasional pain control or low-dose aspirin for cardiovascular prevention as allowed by protocol.
- Oral or rectal corticosteroids and antibiotics must generally be stopped for 30 days before entry. Inhaled and skin corticosteroids are allowed, and brief steroid or antibiotic use during a flare after enrollment may be prescribed by the participant's physician.
Important unknowns
What the record does not make clear
- The record identifies assessments at baseline and around days 180 and 365 but does not report the total number, timing, length, or format of study visits.
- The study has Aquamin and placebo groups but does not report the randomization ratio or each participant's chance of receiving placebo.
- The eligibility criteria restrict several medicines and supplements, but the record does not give a complete list of ulcerative colitis or pouch-related treatments that may continue during the study.
- The criteria allow brief corticosteroid or antibiotic treatment for a flare after enrollment when prescribed by the participant's physician, but the protocol for worsening symptoms and continued study participation is not described.
- The record does not state whether pouchoscopy or another endoscopic examination is required.
- The record does not explain which study-related or routine-care costs are covered or billed to insurance.
- The record does not state whether participants receive compensation.
- The record does not state whether parking, mileage, lodging, or other travel expenses are supported.
- The record does not state whether any visits, questionnaires, or sample collections can be completed remotely or locally.
- The record does not describe whether Aquamin is available after the 365-day study treatment period.
- The title and summary describe prevention of pouch inflammation, while the structured design field labels the primary purpose as treatment.
Before contacting the site
Questions for the study team
- How many study visits are required, where do they occur, and how long does each take?
- What is the chance of assignment to placebo, and when are participants told which group they received?
- Does “within the last eight months” refer to the J-pouch surgery date, ileostomy closure date, or another milestone?
- Must participants be free of pouchitis at baseline, and how is that confirmed?
- What happens if pouchitis symptoms develop, and can antibiotics, corticosteroids, or other rescue treatments be used without leaving the study?
- Are pouchoscopy or other procedures required, and exactly how are urine and fecal assessments collected?
- Which costs are covered, is compensation offered, and is travel or parking support available?
- Is the University of Michigan site currently enrolling people in my age group, and can any activities be completed remotely?
Before changing care
Questions for your gastroenterologist
- Would stopping my calcium, magnesium, fiber supplements, nonsteroidal anti-inflammatory drugs, antibiotics, or oral or rectal corticosteroids for the required period be medically appropriate?
- How stable is my ulcerative colitis and J-pouch condition, and are there clinical concerns with delaying or changing my current management?
- What approved or standard alternatives are available for monitoring or managing pouch inflammation in my situation?
- Do my kidney history, calcium level, bleeding risk, or anticoagulant medicines raise concerns about this study?
- If symptoms worsen during the study, how should you and the research team coordinate testing and treatment?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
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.
Study design and administration
- Organization
- University of Michigan
- Organization class
- Other
- Organization study ID
- HUM00284005
- Lead sponsor
- Muhammad N Aslam, MD
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Triple
- Who is masked
- Participant, Care Provider, Investigator
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Aquamin
Interventions: Drug: Aquamin
Placebo Comparator
Placebo
Interventions: Drug: Placebo
Interventions
Drug
Aquamin
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 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
Placebo
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 measure the lactulose:mannitol ratio to assess gastrointestinal permeability.
Eligibility
5 Years–80 Years
All
Not accepted
Inclusion criteria (3)
- Must be able to give written informed consent (or assent as appropriate)Registry-derived · unreviewed
- Must have the following: UC with ileal pouch-anal anastomosis (IPAA) using a J-pouch without an ileostomy within the last eight monthsRegistry-derived · unreviewed
- For pre-menopausal women 11 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.Registry-derived · unreviewed
Exclusion criteria (12)
- Female subjects must not be pregnant or lactating; and female of childbearing potential unwilling to use acceptable birth control throughout the study.Registry-derived · unreviewed
- Must not be participating in any other interventional trial using an investigational drug.Registry-derived · unreviewed
- Subjects likely to be uncooperative or unable to comply with study proceduresRegistry-derived · unreviewed
- History or diagnosis of Crohn's diseaseRegistry-derived · unreviewed
- History or diagnosis of hereditary gastrointestinal (GI) syndromes, Severe gastrointestinal bleeding/complications, (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors).Registry-derived · unreviewed
- History or diagnosis of any gastrointestinal malignancyRegistry-derived · unreviewed
- 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.)Registry-derived · unreviewed
- Congenital coagulopathies or hereditary hemorrhagic disorders; treatment with therapeutic doses of warfarin or heparinRegistry-derived · unreviewed
- 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:Registry-derived · unreviewed
- Calcium, Magnesium, including multivitamins that have low amounts of Calcium/Magnesium and fiber supplements. (Multivitamins without any minerals are allowed).Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Time to clinical onset of pouchitis using the Modified Pouchitis Disease Activity Index (mPDAI) clinical symptoms section
Time frame: Baseline 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.
Secondary 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.
Secondary outcome
Changes in Serum C-reactive protein (CRP) as marker of inflammation
Time frame: Baseline, Approximately Days 180 and 365
Blood samples will be drawn for C-reactive protein (CRP) levels.
Secondary outcome
Changes in Fecal calprotectin (FCAL) as marker of inflammation
Time frame: Baseline, Approximately Days 180 and 365
Recruiting locations in the United States
University of Michigan
RecruitingAnn Arbor, Michigan, 48109, United States
Lauren Manning734-615-7236lbadish@med.umich.edu
Muhammad N Aslam, MBBS, MD
Central study contacts
Registry dates
- First posted
- Mar 30, 2026
- Primary completion
- May 2029
- Overall completion
- May 2029
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.