Ulcerative Colitis Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 nine months

• For pre-menopausal women 18 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.

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Lauren Manning
lbadish@med.umich.edu
734-615-7236
Time Frame
Start Date: 2026-08
Estimated Completion Date: 2029-05
Participants
Target number of participants: 52
Treatments
Experimental: Aquamin
Placebo_comparator: Placebo
Sponsors
Leads: Muhammad N Aslam, MD
Collaborators: Crohn's and Colitis Foundation

This content was sourced from clinicaltrials.gov