About this trial
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.
Eligibility criteria
Qualifiers
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 eight months
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Aquamin
- Placebo
Treatment groups
Locations
1Sponsors and collaborators
Muhammad N Aslam, MD
Lead sponsor
University of Michigan
Sponsor institution
Crohn's and Colitis Foundation
Collaborator