Aquamin for preventing pouch inflammation in UC patients with a J-pouch

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial will evaluate the safety and potential anti-inflammatory effects of Aquamin® in UC patients with a J-pouch. Eligible participants have undergone IPAA surgery within the last nine months and may not be pregnant; premenopausal women must use contraception. The study uses Aquamin® versus placebo to see if it lowers pouch-related inflammation and supports mucosal health. Key measures include inflammation markers and gut lining integrity, along with regular surveys and sample collection. The trial is conducted at the University of Michigan with collaboration from the Crohn's & Colitis Foundation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* History or diagnosis of hereditary gastrointestinal (GI) syndromes, Severe gastrointestinal bleeding/complications, (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors).
* History or diagnosis of any gastrointestinal malignancy
* Kidney disease, including kidney "stones" or hypercalcemia. acute renal failure (past 12 weeks). (Note: A doubtful stone passed in the urine more than three years ago is not considered evidence of current renal stone disease.)
* Congenital coagulopathies or hereditary hemorrhagic disorders; treatment with therapeutic doses of warfarin or heparin
* Participants will be excluded if they have used any of the following within the past 30 days or are unwilling to withdraw for 30 days prior to entering into the study:

  * Calcium, Magnesium, including multivitamins that have low amounts of Calcium/Magnesium and fiber supplements. (Multivitamins without any minerals are allowed).
  * Non-steroidal anti-inflammatory medications (NSAIDs), such as Naproxen or Ibuprofen (except for occasional pain control or low dose aspirin for cardiovascular disease prevention) per protocol.
  * Oral or rectal Corticosteroids (a type of steroid drug such as prednisone or cortisol that helps the body to regulate stress response, immune response and inflammation) and antibiotics (except these can be used briefly during a flare-up once the study treatment has begun after the subject enrolled, if prescribed by the personal physician). Inhaled and skin corticosteroids preparations are ok and not an exclusion criteria.

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Muhammad N Aslam, MBBS, MD — University of Michigan
• Study coordinator: Lauren Manning
• Email: lbadish@med.umich.edu
• Phone: 734-615-7236

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.