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

NCT07501078 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-03-30

No results posted yet for this 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.

Conditions

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.

Sponsors & Collaborators

  • Crohn's and Colitis Foundation

    collaborator OTHER

  • Muhammad N Aslam, MD

    lead OTHER

Principal Investigators

  • Muhammad N Aslam, MBBS, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-05-31
Completion
2029-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07501078 on ClinicalTrials.gov