Phase 4 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 are a man or woman between 18 and 85 years old (inclusive).
• You have been diagnosed with ulcerative colitis (UC) for at least 90 days, confirmed by a colonoscopy and tissue sample results from the past year.
• You have moderate active UC, confirmed by a specific disease activity score (called a Mayo score) of 6 to 10 at the time of screening.
• You are planned to start treatment with a medication called Vedolizumab for the first time, or are restarting it after not having used it for at least one year.
• Despite trying at least one of the following treatments, your UC has not responded well enough, has stopped responding, or you could not tolerate it: (1) oral aminosalicylate medications (such as mesalamine, sulfasalazine, olsalazine, or balsalazide) taken at standard doses for at least 4 weeks; or (2) immune-suppressing medications (such as azathioprine, 6-mercaptopurine, or methotrexate injections) taken for at least 42 consecutive days at minimum recommended doses.
• Your doses of oral aminosalicylate or immune-suppressing medications have been stable for at least 2 weeks before screening.
• You are willing and able to follow all the rules and restrictions of the study.
• You are willing and able to fill in a daily symptom diary throughout the study.
• You are willing and able to attend all required study visits and phone check-ins.

Who may not be able to join:

• You have been diagnosed with Crohn's disease, a type of colitis that cannot be clearly identified, or another form of colitis.
• Your UC affects only the rectum (the last section of the bowel, less than 15 cm from the anal opening).
• You started taking steroid medications within 2 weeks before your screening visit.
• You used antibiotics for a bowel or other infection within 2 weeks before screening.
• You have used any probiotic supplements within 2 weeks before joining the study.
• You have used rectal (suppository or enema) aminosalicylate medications within 1 week before screening.
• Your oral aminosalicylate or immune-suppressing medication doses were changed due to worsening disease between your colonoscopy screening and enrollment.
• You have taken anti-inflammatory painkillers (NSAIDs, such as ibuprofen) or anti-diarrhea medications for 5 days in a row within 1 week before screening.
• You had a positive test result for a gut infection called Clostridioides difficile within the past month before screening.
• You are pregnant or breastfeeding.
• You are currently using or have previously used other biologic medications or advanced therapies for your condition.
• You have a known allergy to maltose (a type of sugar), cornstarch, or silica.
• You have serious problems with your heart, liver, lungs, kidneys, or blood, or have conditions such as cancer, AIDS, asthma, kidney stones, or kidney problems; or your blood or urine tests show certain abnormal results (confirm with trial site for specific values).

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