Phase 1 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:

• People aged between 18 and 65 years old
• People who are able to sign a written consent form agreeing to take part
• People who have been diagnosed with ulcerative colitis (UC) through a colonoscopy and tissue sample, with a mild to moderate level of disease (based on a specific scoring system called the MMDAI, with a score of 3 to 9)
• People who are currently on a stable dose of aminosalicylate medication (a common UC treatment), with no changes to that dose in the past 4 weeks, and who are not planning to start any new medications during the trial
• People who agree to use an approved form of birth control during the study and for at least 30 days after the last dose — this applies to women who could become pregnant, and to men whose partners could become pregnant; men must also agree not to donate sperm during this period
• People in the expansion group of the trial may need to have a flexible sigmoidoscopy (a camera examination of part of the bowel), unless a similar procedure was completed within the past 3 months (confirm with trial site)
• People who agree not to receive any vaccinations during the study period (including flu, COVID-19, shingles, tetanus, hepatitis, pneumonia, HPV, and others)

Who may not be able to join:

• People who are pregnant, planning to become pregnant, or currently breastfeeding
• People with severe UC, defined as a MMDAI score of 10 or higher
• People with any current or recent infection, or ongoing infectious diseases such as Hepatitis B, Hepatitis C, or HIV
• People with an active or recent chronic chest or sinus infection, or who have had COVID-19 in the past 3 months
• People who have used certain immune-suppressing or anti-cancer medications in the past 3 months — including drugs such as azathioprine, methotrexate, anti-TNF agents, or similar treatments (confirm with trial site for the full list)
• People who have taken part in another clinical trial or received an experimental drug within the past 3 months (or longer, depending on the drug)
• People currently using steroid medications to treat UC, such as prednisone at doses above 20 mg per day
• People who have used probiotic supplements within the past week, or who plan to use them during the trial
• People who have taken broad-spectrum antibiotic medications in the past 2 months
• People with another major active autoimmune disease in addition to UC
• People with a history of severe allergic reactions (anaphylaxis) or allergies to probiotics
• People with a history of alcohol or drug misuse within the past 2 years
• People with a history of stroke or any blood vessel disease affecting the brain that requires treatment
• People with a history of cancer, except for certain skin cancers or cervical abnormalities that were successfully treated more than 1 year before joining the trial
• People with significantly abnormal liver test results (above 1.5 times the accepted normal range)
• People with certain heart rhythm or electrical conduction problems (confirm with trial site)
• People with significant kidney, liver, blood, or other health conditions that the trial doctor believes could affect safety or the reliability of results
• People with any other condition that, in the trial doctor's judgement, could put them at risk or affect the quality of the study

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