Primary Biliary Cholangitis 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:

PSC Patients:

• People who are willing to follow all study procedures and are available for the full duration of the study
• Men or women who are not pregnant, aged 18 or older
• People who have been diagnosed with PSC (primary sclerosing cholangitis) confirmed by blood tests and a specific type of bile duct imaging (MRCP or ERCP), with evidence of disease in the larger bile ducts shown on imaging
• People who agree to follow certain lifestyle guidelines throughout the study

Control Participants (comparison group):

• Men or women aged 18 or older
• People who are either a parent, sibling, or child of a PSC patient enrolled in the study, or someone unrelated who has been living with the PSC patient for at least 3 consecutive months before the study begins

Who may not be able to join:

PSC Patients:

• Women who are pregnant, breastfeeding, or of childbearing age who are not using measures to prevent pregnancy during the study
• People who have evidence of a chronic liver disease caused by something other than PSC
• People who have had a liver transplant
• People whose condition appears to be a different type of bile duct scarring disorder (called secondary sclerosing cholangitis), such as that caused by gallstones, reduced blood flow to the bile ducts, or HIV-related bile duct disease
• People who have had, or currently have, signs of serious liver complications such as fluid build-up in the abdomen, bleeding from veins in the food pipe, brain function problems related to liver disease, or serious infections in the abdomen
• People with a history of growths in the liver or bile ducts that may be cancerous
• People with certain blood marker levels above specified limits, including CA 19-9 above 130 U/microL or alpha-fetoprotein above 200 ng/microL (confirm with trial site for what these tests involve)
• People who currently have an active bacterial, viral, or fungal infection anywhere in the body
• People who are unwilling to avoid taking probiotic supplements during the study
• People with a poorly controlled serious medical condition unrelated to PSC, such as poorly controlled diabetes, significant kidney disease, chronic heart failure, or severe chronic lung disease
• People with a history of any cancer of the digestive system within the last 3 years, or any other cancer within the last 3 years, unless a treating doctor has determined the person had curative surgery and is considered low risk for the cancer returning
• People with a history of a blood clot in the portal vein (the main vein supplying the liver)
• People with a history of severe allergic reactions to iodine or contrast dye used in medical imaging, which cannot be managed with allergy medications
• People who have had surgery on the stomach or upper small intestine, including weight loss surgeries such as gastric bypass
• People for whom sedation medications used during digestive tract procedures (endoscopy) would not be safe
• People currently using blood-thinning or anti-clotting medications (excluding aspirin and anti-inflammatory pain relievers such as ibuprofen)
• People for whom an MRI or MRCP scan would not be safe
• People whose blood test results fall outside acceptable ranges, including low white blood cell counts, low red blood cell levels (haemoglobin below 10.0 g/dl), low platelet counts, or abnormal blood clotting results
• People who are unable to give informed consent to participate

Control Participants:

• People with any history suggesting they may have PSC
• People with a history of chronic liver disease (other than fatty liver)
• People with a history of any cancer in the 3 years prior to joining, unless a treating doctor has determined the person had curative surgery and is considered low risk for the cancer returning
• People with a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
• People who have used antibiotics within the 6 weeks before joining the study
• People who are pregnant
• People who are unable to give informed consent to participate

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