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RecruitingNCT07501078Updated Sep 11, 2026

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

A Phase 2 interventional study of Aquamin and Placebo in Ulcerative Colitis and Ileal Pouch, sponsored by Muhammad N Aslam, MD. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Muhammad N Aslam, MD · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Ulcerative Colitis
  • Ileal Pouch

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Keywords

  • J-pouch without an ileostomy
  • Surveys
  • Sample collection
  • Placebo
  • Aquamin®
  • Randomization
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    Aquamin

    Drug: Aquamin

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugAquamin

    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.

  • DrugPlacebo

    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.

    Also known as: Maltodextrin

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline up to day 365

Secondary outcomes

  1. Changes in Intestinal permeability assessed by urinary Lactulose/mannitol urinary ratio

    Lactulose/mannitol excretion after oral load.

    Time frame: Baseline, Approximately Days 180 and 365

  2. Changes in Serum C-reactive protein (CRP) as marker of inflammation

    Blood samples will be drawn for C-reactive protein (CRP) levels.

    Time frame: Baseline, Approximately Days 180 and 365

  3. Changes in Fecal calprotectin (FCAL) as marker of inflammation

    Time frame: Baseline, Approximately Days 180 and 365

06

Study locations

1 of 1 sites recruiting
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
    • Lauren Manning · Contact · lbadish@med.umich.edu · 734-615-7236
    • Muhammad N Aslam, MBBS, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07501078
Lead sponsor
Muhammad N Aslam, MD
Collaborators
Crohn's and Colitis Foundation
Responsible party
Muhammad N Aslam, MD (Associate Research Scientist, University of Michigan) — Sponsor-investigator
First posted
Mar 30, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jun 2029 (estimated)
Completion
Jun 2029 (estimated)
Last update
Sep 11, 2026

Study contacts

Lauren Manning
Contact
lbadish@med.umich.edu
734-615-7236
Muhammad N Aslam, MBBS, MD
principal investigator · University of Michigan

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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