Phase 2 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You must be able to read and sign a consent form agreeing to take part (or, if appropriate, give your agreement in another acceptable way).
• You must have ulcerative colitis (a type of bowel disease) and have had a specific surgery called a J-pouch procedure — where part of your bowel was reshaped into a pouch connected to your anal passage — within the last eight months, and you must no longer have a stoma bag (ileostomy).
• If you are a woman aged 11 or older who has not yet gone through menopause and still has your reproductive organs, you must have a negative pregnancy test within two weeks before your first study visit, and you must agree to use an acceptable form of birth control throughout the study.

Who may not be able to join:

• Women who are pregnant or currently breastfeeding, or women who could become pregnant but are not willing to use acceptable birth control during the study, cannot take part.
• You cannot currently be taking part in another clinical trial that uses an experimental drug or treatment.
• People who are unlikely to be able to follow the study's instructions or attend required appointments cannot take part.
• You cannot join if you have ever been diagnosed with Crohn's disease (another type of bowel disease).
• You cannot join if you have a history of certain inherited bowel conditions, serious bowel bleeding or complications, or tumors that cause excess stomach acid (confirm with trial site).
• You cannot join if you have ever been diagnosed with any cancer of the digestive system.
• You cannot join if you have kidney disease, kidney stones, high calcium levels in your blood, or if you have had sudden kidney failure in the last 12 weeks. (Note: if you may have passed a kidney stone more than three years ago but have had no problems since, this may not exclude you — confirm with trial site.)
• You cannot join if you have a hereditary blood clotting disorder or a condition that causes abnormal bleeding, or if you are currently taking high doses of blood-thinning medicines such as warfarin or heparin.
• You cannot join if you have used any of the following in the past 30 days, or are unwilling to stop using them for 30 days before starting the study:
  • Calcium or magnesium supplements, including most multivitamins that contain these minerals or fiber supplements. (Multivitamins that contain no minerals at all are allowed.)
  • Anti-inflammatory painkillers such as ibuprofen or naproxen, except for occasional pain relief or low-dose aspirin taken to protect your heart.
  • Steroid tablets or rectal steroid treatments (such as prednisone) or antibiotic medicines — though these may be allowed briefly if your own doctor prescribes them during a flare-up after you have already joined the study. Steroid inhalers or steroid creams applied to the skin are allowed and will not exclude you.

Important: Always verify eligibility with the trial site directly before applying.