Printed from Voxsanity (voxsanity.com.au) — NCT06197308 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Primary Biliary Cholangitis
Early Phase 1 Primary Biliary Cholangitis Trial, Recruiting
NCT06197308
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 18 and 76 years old
- Your blood test shows that your bilirubin level (a measure of liver function) is not more than twice the upper limit of normal
- A recent scan (within the last 6 months) has shown no blockage in your bile ducts and no signs of cancer
- You are expected to stay on your current medications throughout the study (such as UDCA, azathioprine, steroids, methotrexate, or similar treatments)
- You have not taken obeticholic acid or other experimental PSC treatments for at least 3 months before joining
- You are willing and able to follow all study requirements, including check-ins by phone, in person, email, or video call
- You are able to give your informed consent to take part
Who may not be able to join:
- You have taken antibiotics (other than vancomycin) in the last 3 months, or you are expected to need antibiotics during the treatment period
- You have serious complications from advanced liver disease, such as fluid build-up in the abdomen, confusion caused by liver failure, swollen veins in the food pipe, or related conditions
- You have an active hepatitis B or HIV/AIDS infection (a past hepatitis C infection may be acceptable if the virus is no longer detectable — confirm with trial site)
- You have a genetic or metabolic liver condition, such as Wilson's disease, hemochromatosis, or alpha-1-antitrypsin deficiency
- You have another condition affecting your bile ducts, such as primary biliary cholangitis or IgG4-related cholangitis
- A recent scan (within 6 months) has shown signs of severe scarring of the liver (cirrhosis)
- You are pregnant, trying to become pregnant, or currently breastfeeding
- You have previously had a liver transplant, are expected to need one within 12 months, or your liver disease severity score (called a MELD score) is 15 or higher
- You currently have an active cancer
- You regularly drink more than 4 alcoholic drinks per day (men) or more than 2 per day (women)
- Your kidneys are not working well enough (confirmed by a specific blood test measuring kidney function — confirm with trial site)
- Your white blood cell count is very low, which can affect your ability to fight infection (confirm with trial site)
- You have had an allergic reaction to vancomycin in the past
- You have had an allergic reaction to amoxicillin or similar antibiotics (known as beta-lactam antibiotics)
- You have had your entire large bowel (colon) surgically removed
- You have any other condition that the study doctor believes could affect your safety or ability to complete the trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Early Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
1 March 2024
Est. completion
31 March 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
To evaluate safety of MTT in patients with PSC; To evaluate feasibility of MTT in patients with PSC
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.