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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-80
SponsorMuhammad N Aslam, MD

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

52 Participants
are divided into 2 treatment groups

Locations

1
University of Michigan48109, Ann ArborMichigan, United States

Sponsors and collaborators

Muhammad N Aslam, MD

Lead sponsor

University of Michigan

Sponsor institution

Crohn's and Colitis Foundation

Collaborator