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:

• Adults between 18 and 75 years of age at the time of screening
• People with a confirmed diagnosis of ulcerative colitis that was made at least 3 months before screening, based on standard medical tests
• People whose ulcerative colitis is currently mild to moderate in severity, based on a standard scoring tool used at screening
• People who have some rectal bleeding at the time of screening
• People with a stool test result showing a certain level of bowel inflammation (fecal calprotectin of at least 250 micrograms per gram), confirmed by the trial's laboratory
• People whose ulcerative colitis affects the left side of the colon or a larger portion of the colon; those with a more limited area of inflammation may be eligible in some cases (confirm with trial site)
• People who are either not currently taking any ulcerative colitis medication, or who have been on a stable, unchanged dose of a specific anti-inflammatory bowel medication (called 5-ASA or mesalamine, taken by mouth or rectally) for at least 8 weeks before joining, and who intend to keep that dose the same throughout the first 24 weeks of the trial
• People who are willing and able to give written consent to take part
• People who are able to attend trial visits, complete diary entries, provide stool samples, and follow the study requirements
• People who are able to have children and who agree to use a reliable method of contraception during the trial and for at least 4 weeks after the last dose

Who may not be able to join:

• People with a different type of bowel condition, such as Crohn's disease, microscopic colitis, or colitis caused by infection, reduced blood flow, or radiation
• People whose ulcerative colitis is severe, rapidly worsening, or requires urgent hospital treatment
• People with inflammation limited only to the very last section of the bowel (isolated proctitis), if the trial's enrollment limit for this group has already been reached
• People who have used certain strong immune-modifying medications — including biologics, JAK inhibitors, S1P receptor modulators, or systemic immunosuppressants — within 8 weeks before joining, or who plan to use them during the trial
• People who have taken steroid tablets or injections affecting the whole body within 4 weeks before joining
• People currently taking a budesonide-type medication at the start of the trial
• People using steroid creams or suppositories unless these were stopped at least 2 weeks before joining
• People who have taken antibiotics within 4 weeks before joining (with some exceptions for topical antibiotics that do not affect the gut)
• People who have used probiotic, prebiotic, or other gut microbiome-directed supplements within 4 weeks before joining, or who plan to use them during the trial
• People who have had a confirmed bowel infection with a bacteria called Clostridioides difficile within 12 weeks before screening
• People whose stool test at screening shows a current bowel infection of any relevant type
• People who have previously had their colon surgically removed, are planning to have it removed, have been found to have pre-cancerous changes in the bowel requiring treatment, or have colorectal cancer
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial
• People with other serious or uncontrolled health conditions — such as uncontrolled diabetes, advanced kidney or liver disease, unstable heart disease, a weakened immune system, or an active cancer (other than certain treated skin cancers) — that could affect safety or the reliability of results
• People with a known allergy or sensitivity to any ingredient in the trial medication or placebo
• People who have taken part in another interventional clinical trial within 30 days before screening
• People whom the trial investigator considers unsuitable for participation for any other safety or protocol reason

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