Phase 3 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 75 years old.
• People who have had ulcerative colitis (a type of inflammatory bowel disease) confirmed by a camera examination of the bowel at least 6 months ago, with the disease affecting at least 15 cm of the bowel from the back passage.
• People whose ulcerative colitis is currently active, based on a specific scoring system used by doctors to measure disease activity (called the Mayo Score).
• People whose ulcerative colitis has not responded well enough to standard treatments or to more advanced medicines (called biologics or small molecules).
• People who are currently taking certain ulcerative colitis medicines at a stable dose for a set period before joining — including anti-inflammatory tablets (5-ASA), immunosuppressants (such as azathioprine, 6-MP, or methotrexate), low-dose oral steroids, or topical (locally applied) treatments (confirm with trial site for specific dose and timing requirements).
• People who have either been vaccinated against COVID-19, previously had a COVID-19 infection, or have a blood test showing immunity to COVID-19.
• People who are able to understand the trial and are willing to sign a consent form agreeing to take part.
• People who could potentially become pregnant must have a negative pregnancy test and must be using a highly effective form of contraception.

Who may not be able to join:

• People diagnosed with Crohn's disease, indeterminate colitis, or ulcerative colitis limited only to the very end of the bowel (proctitis alone).
• People experiencing a sudden, severe bowel emergency (such as a severely swollen colon, serious bowel bleeding, bowel blockage, or bowel perforation).
• People who have previously had surgery on their colon, including full or partial removal.
• People who currently have an active infection in their digestive system.
• People with a weakened immune system, whether from birth or due to illness or treatment.
• People with serious other health conditions, such as insulin-dependent diabetes, severe liver disease, a specific liver-bile duct condition (primary sclerosing cholangitis), or significant kidney problems (confirm with trial site for exact definitions).
• People who have been diagnosed with cancer in the past 3 years.
• People who are unwilling to have bowel camera examinations with video recording as part of the trial.
• People who have never received any specific treatment for their ulcerative colitis.
• People who have no confirmed immunity to COVID-19.
• People who have been treated with certain advanced medicines (TNF, IL-12/23, IL-23, or integrin antibody treatments) within the 8 weeks before joining.
• People who have been treated with calcineurin inhibitor medicines within the 4 weeks before joining.
• People who have been treated with JAK inhibitor medicines (such as tofacitinib, filgotinib, or upadacitinib) within the 4 weeks before joining.
• People who have been treated with S1P receptor modulator medicines (such as ozanimod or etrasimod) within the 4 weeks before joining.
• People who have taken antibiotic medicines (taken throughout the body, not just locally) within the 8 weeks before joining.
• People with a known allergy or intolerance to metronidazole or vancomycin (specific antibiotics).
• People who have previously received a faecal microbiota transplant (a treatment using donor stool), or who have previously taken part in this specific trial (initial screening visits may still be allowed — confirm with trial site).
• People who have participated in another clinical trial within the past 3 months.
• People who have used probiotic supplements in tablet, capsule, or powder form, or probiotic drinks or yogurts, within the 2 weeks before joining.
• People who are unable to store the trial treatment in a freezer as required.
• People with substance dependency or other conditions that may prevent them from fully understanding what taking part in the trial involves.
• People who are considered unlikely to follow the trial requirements or who are unwilling to cooperate with the trial process.

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