Phase 1 Primary Biliary Cholangitis Trial, Completed (NCT01322386)

Phase 1 Primary Biliary Cholangitis Trial, Completed NCT01322386 Sponsor: Stanford University Condition: Primary Biliary Cholangitis

Printed from Voxsanity (voxsanity.com.au) — NCT01322386 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Primary Biliary Cholangitis

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 the use of oral vancomycin (an antibiotic taken by mouth) in two groups of patients with liver conditions: those with biliary atresia (a condition where the bile ducts are blocked or missing) and those with primary sclerosing cholangitis, or PSC (a condition where the bile ducts become inflamed and scarred). Ten people were enrolled in the biliary atresia group and eleven in the PSC group. All ten participants in the biliary atresia group completed the study, while nine of the eleven PSC participants completed it, with two not finishing. The reported data shows that the trial measured possible changes using liver blood tests, MRI scans (a type of imaging), liver biopsies (small tissue samples from the liver), and colon biopsies (small tissue samples from the large bowel). For the biliary atresia group, the reported data shows that 10 out of 10 participants had liver blood test results recorded, but no MRI scans, liver biopsies, colon biopsies, or combined biopsy/MRI results were reported for this group. For the PSC group, the reported data shows 9 out of 9 participants had liver blood tests recorded, 7 had MRI scans, 4 had liver biopsies, 8 had colon biopsies, and 8 had either a liver biopsy and/or MRI. The data as submitted does not include the actual before-and-after numbers or results from these tests, only the counts of how many participants had each measurement taken. 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 32633158) ↗

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.

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 biliary atresia (a liver condition affecting bile ducts, usually in infants) or primary sclerosing cholangitis (a disease causing scarring and narrowing of the bile ducts)
You are a healthy comparison participant who is already scheduled to have a camera examination of the stomach or bowel, and you do not have biliary atresia or primary sclerosing cholangitis
You have been taking oral vancomycin (an antibiotic medication) by mouth for at least 1 year for biliary atresia (confirm with trial site for full details of this criterion)

Who may not be able to join:

You have taken any antibiotic medicines in the last 3 months, as this can change the natural balance of bacteria in your body

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.

Last synced 28 July 2026

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT01322386

Sponsor: Stanford University

Phase: Phase 1

Status: Completed

Condition: Primary Biliary Cholangitis

More information: https://clinicaltrials.gov/study/NCT01322386

Eligibility summary (AI generated)

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:

You have been diagnosed with biliary atresia (a liver condition affecting bile ducts, usually in infants) or primary sclerosing cholangitis (a disease causing scarring and narrowing of the bile ducts)
You are a healthy comparison participant who is already scheduled to have a camera examination of the stomach or bowel, and you do not have biliary atresia or primary sclerosing cholangitis
You have been taking oral vancomycin (an antibiotic medication) by mouth for at least 1 year for biliary atresia (confirm with trial site for full details of this criterion)

Who may not be able to join:

You have taken any antibiotic medicines in the last 3 months, as this can change the natural balance of bacteria in your body

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Completed

Phase

Phase 1

Sponsor

Stanford University

Registry

ClinicalTrials.gov

Start date

1 May 2007

Est. completion

1 October 2010

Primary endpoints

Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

View original record on ClinicalTrials.gov