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Vancomycin for Primary Sclerosing Cholangitis

Phase 2 & 3
Recruiting
Led By Elizabeth Carey, MD
Research Sponsored by Elizabeth Carey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of PSC consistent with the guidelines published by the American Association for the Study of Liver Diseases (AASLD). All subjects must have an elevated serum ALP of at least 1.5 times upper limit of normal at baseline plus cholangiographic evidence of PSC, as demonstrated by magnetic resonance imaging, endoscopic retrograde cholangiography, direct cholangiography, or liver biopsy.
Male or female subject age 18-76 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing whether vancomycin is a safe and effective treatment for primary sclerosing cholangitis.

Who is the study for?
Adults aged 18-76 with Primary Sclerosing Cholangitis (PSC) can join this trial. They must have certain liver test results and imaging that confirms PSC without other liver diseases or complications like cancer. Stable doses of specific medications are allowed, but no antibiotics in the last 3 months or recent experimental therapies for PSC without a washout period.Check my eligibility
What is being tested?
The trial is testing if vancomycin is safe and effective for treating PSC compared to a placebo. Participants will be randomly assigned to receive either vancomycin or an inactive substance, with neither the participants nor the researchers knowing who receives which treatment until after the study ends.See study design
What are the potential side effects?
Vancomycin may cause side effects such as allergic reactions, kidney problems, hearing issues, and infusion-related reactions like redness and pain where injected. The severity of these side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PSC and meet the AASLD guidelines, including high ALP levels and confirmed by imaging or biopsy.
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I am between 18 and 76 years old.
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I have PSC, with or without a condition like ulcerative colitis or Crohn's disease.
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I have PSC with high ALP levels and confirmed by specific liver tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alkaline phosphatase at 12 months
Alkaline Phosphatase
Alkaline phosphatase at 3 months post treatment = 21 months
+2 more
Secondary outcome measures
Fibroscan, cholangiography

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VancomycinExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2005
Completed Phase 4
~7930

Find a Location

Who is running the clinical trial?

Elizabeth CareyLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Arizona State UniversityOTHER
283 Previous Clinical Trials
109,412 Total Patients Enrolled
Elizabeth Carey, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital
Illinois Medical College (Medical School)
2 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT03710122 — Phase 2 & 3
Primary Sclerosing Cholangitis Research Study Groups: Placebo, Vancomycin
Primary Sclerosing Cholangitis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT03710122 — Phase 2 & 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT03710122 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what sorts of infections is Vancomycin generally prescribed?

"Vancomycin can be used to effectively treat staphylococcal infections, infection caused by staphylococci, and enterocolitis caused by staphylococcus aureus."

Answered by AI

Are people with the illness under study still being sought for this experiment?

"This clinical trial, which was first posted on 1/23/2020, is actively recruiting patients. The last update to the listing was on 8/24/2022."

Answered by AI

What other scientific studies have included Vancomycin in their research?

"Vancomycin was first trialled in 2010 at Sacramento Pediatric Gastroenterology. To date, there have been 18,384 completed vancomycin trials. Right now, there are 60 active vancomycin trials taking place, with a significant portion based in Rochester, Minnesota."

Answered by AI

Would it be possible for me to take part in this research?

"The requirements to participate in this particular clinical trial is having a diagnosis of cholangitis, sclerosing and being within the age range of 18 to 76 years old. Right now, they are looking to enroll 102 individuals."

Answered by AI

Does this experiment allow for adolescents?

"The age limits for this trial are set at 18 and 76 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vancomycin for Primary Sclerosing Cholangitis
Elizabeth Carey 2020. "Vancomycin for Primary Sclerosing Cholangitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03710122.
~38 spots leftby Oct 2026
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