Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial looked at two antibiotics — vancomycin and metronidazole — each tested at a low and a high dose, in people with a liver condition called primary sclerosing cholangitis (PSC). A total of 35 people were enrolled across the four groups (8 on low-dose vancomycin, 9 on high-dose vancomycin, 9 on low-dose metronidazole, and 9 on high-dose metronidazole), and 28 completed the full 12 weeks. The trial measured changes in several blood markers over that period, with the main focus being a liver enzyme called alkaline phosphatase (ALP) — a substance found in the blood that doctors sometimes monitor in liver conditions. The reported data shows that after 12 weeks, ALP levels changed by different amounts in each group. In the low-dose vancomycin group, ALP dropped by an average of 117 units per litre (U/L); in the high-dose vancomycin group, it dropped by 49 U/L; in the low-dose metronidazole group, it dropped by 62 U/L; and in the high-dose metronidazole group, it dropped by 36 U/L. The reported data also shows changes in three secondary measures. For total bilirubin (another liver marker), levels fell slightly in the low-dose groups (−0.4 and −0.3 mg/dL for vancomycin and metronidazole respectively) but showed a small rise in both high-dose groups (+0.05 mg/dL each). A disease severity score called the Mayo PSC Risk Score — where higher numbers indicate worse disease — fell in all four groups, with the largest reported drop in the low-dose vancomycin group (−0.65). Finally, a general inflammation marker called C-reactive protein fell in the two low-dose groups (−2.2 and −3.6 mg/L) and showed little to no change in the high-dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 23384404) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 1 Primary Biliary Cholangitis Trial, Completed
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 have been diagnosed with Primary Sclerosing Cholangitis (PSC), shown by abnormal liver blood test results that have been elevated for at least 6 months.
- A special imaging test of your bile ducts (such as an ERCP or MRCP) has shown blockages, narrowing, or irregular shapes in the bile ducts consistent with PSC.
- You are either male or female.
- You are 18 years of age or older, but younger than 75 years old.
- You are willing and able to give your consent to take part in the study.
Who may not be able to join:
- You have taken certain medications in the past three months, including specific antibiotics, steroids, or immune-suppressing drugs (confirm with trial site for the full list).
- You are currently using recreational drugs or drinking alcohol heavily.
- You have had an allergic reaction in the past to the type of antibiotics used in this study (confirm with trial site for specifics).
- You have a condition that the study doctor believes would make it unsafe or difficult for you to complete the study.
- Your liver disease has reached a serious stage, for example you have had repeated episodes of internal bleeding, fluid build-up that cannot be controlled, or episodes of confusion caused by liver failure.
- Your doctor expects you may need a liver transplant within the next year.
- Your liver problems appear to be caused by something other than PSC, such as hepatitis B or C, alcoholic liver disease, or other specific liver conditions.
- You are currently pregnant or breastfeeding, or if you become pregnant during the study you would need to withdraw.
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.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment
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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.