NCT07501078

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Muhammad N Aslam, MD · Academic / Other
• Sex: All
• Age: 5 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis
• Ileal Pouch

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study