Study of Aquamin to Reduce Inflammation and Prevent Pouchitis in People with Ulcerative Colitis Having a J-Pouch

What this Trial Is About

Ulcerative colitis UC is a condition causing long-term inflammation in the digestive tract, often leading to surgery that creates a J-pouch for stool. Some people with this pouch develop pouchitis, an inflammation problem with limited treatment options and no known prevention methods. This phase 2 study evaluates whether a natural mineral supplement called Aquamin4 can reduce inflammation and protect the gut lining in people with a UC J-pouch, potentially lowering the risk of pouchitis. Participants will be randomly assigned to take either Aquamin4 or a placebo for one year. Aquamin4 is given orally as 2400 milligrams daily about 800 milligrams calcium in capsules taken twice or all at once. If swallowing capsules is difficult, they can be opened and mixed with liquid or soft food. Participants will also take lactulose and mannitol at the start, middle, and end of the study to measure gut permeability. During the study, participants will be monitored for the time to onset of pouchitis symptoms using a clinical index. Researchers will assess intestinal permeability, inflammation markers like serum C-reactive protein and fecal calprotectin at baseline, 6 months, and 12 months. The study includes safety monitoring and aims to understand how Aquamin4 may impact gut health and inflammation over the one-year treatment period.

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