University of Michigan
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
Location contact
Lauren Manning
CONTACT
Muhammad N Aslam, MBBS, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07501078
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.
Interested in participating?
Request Info5 year–80 year
All sexes
Interventional
Phase 2
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
Lauren Manning
CONTACT
Muhammad N Aslam, MBBS, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Other names: Maltodextrin
Time frame: Baseline up to day 365
The Modified Pouchitis Disease Activity Index was developed for diagnosing active pouchitis and quantifying the severity of pouchitis. The index includes the clinical criteria of 1) stool frequency 2) rectal bleeding 3) Fecal Urgency/Abdominal Cramps and 4) presence or absence of fever. Scores range from 0-6 (without endoscopic measures). The higher the score, the worse the disease activity.
Time frame: Baseline, Approximately Days 180 and 365
Lactulose/mannitol excretion after oral load.
Time frame: Baseline, Approximately Days 180 and 365
Blood samples will be drawn for C-reactive protein (CRP) levels.
Time frame: Baseline, Approximately Days 180 and 365
Contact information is provided by the study sponsor or research team.
Muhammad N Aslam, MD
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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