RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Aquamin®, a natural mineral supplement, is safe and can reduce gut swelling and protect the gut lining. It is for people with ulcerative colitis (UC) who have a J-pouch made during surgery to remove the colon. Researchers hope it may help prevent pouchitis, or swelling in the pouch.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can give written consent, or assent when appropriate, to join the study.
  • Have UC and a J-pouch connected to the anus, with no ileostomy (an opening in the belly for stool) within the last 9 months.
  • Women age 18 or older who have not reached menopause and have intact reproductive organs must have a negative pregnancy test within 2 weeks before the first study visit and agree to use approved birth control during the study.

Who can't join

  • Are pregnant or breastfeeding, or could become pregnant but will not use approved birth control.
  • Are in another trial testing an experimental drug, or are unlikely or unable to follow study steps.
  • Have a history or diagnosis of Crohn’s disease, inherited digestive tract disorders, severe digestive tract bleeding or problems, or cancer in the digestive tract.
  • Have kidney disease, kidney stones, high blood calcium, or sudden kidney failure in the past 12 weeks. A possible stone passed more than 3 years ago does not count as current kidney stone disease.
  • Were born with a blood-clotting or bleeding disorder, or take treatment doses of the blood thinners warfarin or heparin.
  • Used calcium, magnesium, fiber supplements, or vitamins containing calcium or magnesium in the past 30 days, or will not stop them for 30 days before joining. Vitamins without minerals are allowed.
  • Used anti-inflammatory pain drugs such as ibuprofen or naproxen in the past 30 days, or will not stop them for 30 days before joining. Occasional pain use and low-dose aspirin to prevent heart disease are allowed under study rules.
  • Used steroids taken by mouth or rectum, or antibiotics, in the past 30 days, or will not stop them for 30 days before joining. Inhaled and skin steroids are allowed. After study treatment starts, a personal doctor may prescribe brief steroid or antibiotic use for a flare-up.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

MI