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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Muhammad N Aslam, MD
Study ID
NCT07501078
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 80 Years
Healthy Volunteers
Not accepted

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 also take lactulose and mannitol on days day 0, day 180, and day 365 to measure the lactulose:mannitol ratio to assess gastrointestinal permeability.
  • 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 measure the lactulose:mannitol ratio to assess gastrointestinal permeability.

Study Details

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.

Key Dates

First listed
Mar 30, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aquamin
  • Placebo Comparator: Placebo

Primary Outcome Measure

Time to clinical onset of pouchitis using the Modified Pouchitis Disease Activity Index (mPDAI) clinical symptoms section [ Time Frame: Baseline up to day 365 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Lauren Manning
[email protected]
734-615-7236
Muhammad N Aslam, MBBS, MD (PRINCIPAL_INVESTIGATOR)

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By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
University of Michigan· Ann Arbor, MI

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