Phase 2 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the 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 who are willing and able to give their informed consent to participate
• People aged 18 to 89 years old
• People who speak English
• People with a confirmed diagnosis of Crohn's disease (CD), based on typical clinical and tissue examination findings
• People with active Crohn's disease shown on a camera examination of the bowel (colonoscopy), with disease activity scores meeting specific thresholds (confirm with trial site)
• People whose current Crohn's disease treatments are in the ongoing maintenance (regular upkeep) phase at the time of joining the trial
• People whose Crohn's disease medications (other than steroids) have been at a stable, unchanged dose for at least 4 weeks before joining, and are expected to remain stable throughout the study
• People whose steroid use is at 20mg or less at least 5 days before joining the trial
• People taking the steroid prednisone, provided the dose is reduced below 20mg after 7 days
• People taking the steroid budesonide during the study period (tapering is encouraged but not required)
• Women who are either post-menopausal, surgically unable to become pregnant, or who agree to remain abstinent or use a highly effective form of contraception throughout the study (note: periodic abstinence and withdrawal are not considered acceptable methods)
• People who, in the opinion of the study team, are able to follow the study requirements

Who may not be able to join:

• People who have had extensive bowel removal surgery, such as removal of most of the large bowel or a large portion of the small bowel, where short bowel syndrome could be a concern
• People with a diagnosed condition where the stomach does not empty properly (gastroparesis)
• People who have had certain types of stomach surgery that alter the normal passage of food, such as Roux-en-Y gastric bypass
• People with a significant bowel narrowing (stricture) that cannot be passed by the colonoscope, requires a procedure to pass through, or is causing most of the current symptoms
• People who have an ileostomy or colostomy (a surgical opening on the abdomen for waste)
• People with a fistula (an abnormal connection) between the bowel and the bladder
• People with suspected ischemic colitis, radiation colitis, or microscopic colitis (different types of bowel inflammation)
• People with a diagnosis of ulcerative colitis
• People with an active or untreated infection
• People with adenomatous polyps (certain growths in the bowel) that have not yet been removed
• People who have used antibiotics within 14 days of joining the trial
• People who are currently pregnant
• People who are currently breastfeeding or plan to breastfeed during the study
• People with a history of severe (anaphylactic) food allergies
• People with advanced liver disease or liver scarring (cirrhosis)
• People who are expected to need antibiotics at any point during the study
• People who are expected to need surgery at any point during the study
• People with a very low level of a specific type of white blood cell (neutrophil count below 500 cells/µL) (confirm with trial site)
• People with a diagnosis of a primary immune system deficiency
• People with an active cancer currently being treated with chemotherapy (except for certain localised skin cancers)
• People currently receiving cytotoxic (cell-destroying) therapy for solid tumours or blood cancers
• People who have had a solid organ transplant within the 6 months before joining the trial
• People who have received CAR T-cell therapy or a bone marrow/stem cell transplant within the past 12 months
• People with a life expectancy of 6 months or less

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