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Antibiotic

Vancomycin for Primary Sclerosing Cholangitis

Phase 1
Recruiting
Led By Yinka Davies, M.D.
Research Sponsored by Sacramento Pediatric Gastroenterology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Persons who have primary sclerosing cholangitis, biliary atresia, a chronic intestinal disorder, or who are undergoing upper or lower endoscopy
Be younger than 65 years old
Must not have
Patients that have taken antibiotics and/or immunomodulators within the last 3 months will be excluded as this will alter the original bacterial flora
Females who are pregnant may not participate.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 5 Other Conditions

Summary

This trial will study the effects of vancomycin on biliary atresia and primary sclerosing cholangitis. It will also study the microbiome of the intestine and its interactions with the human host.

Who is the study for?
This trial is for individuals with primary sclerosing cholangitis or biliary atresia, who are suitable for vancomycin treatment. It's also open to those with chronic intestinal disorders or undergoing endoscopy. People can't join if they've used antibiotics/immunomodulators in the last 3 months or if they're pregnant.
What is being tested?
The study aims to see if vancomycin effectively treats early-stage Biliary Atresia and Primary Sclerosing Cholangitis, and how it interacts with gut microbes.
What are the potential side effects?
Vancomycin may cause side effects like digestive issues, kidney problems, hearing loss, and allergic reactions such as rashes or difficulty breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a liver or intestinal condition, or I'm getting an endoscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken antibiotics or immunomodulators in the last 3 months.
Select...
I am not pregnant.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia

Side effects data

From 2021 Phase 4 trial • 15 Patients • NCT03388268
25%
Abdominal pain
13%
Syncope, altered mental status
13%
Volume overload
13%
Hypoxemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Oral Vancomycin

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral VancomycinExperimental Treatment1 Intervention
Every participant with PSC or BA will received the same Arm of Oral Vancomycin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sacramento Pediatric GastroenterologyLead Sponsor
Yinka Davies, M.D.Principal InvestigatorSacramento Pediatric Gastroenterology

Media Library

Vancomycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02137668 — Phase 1
Biliary Atresia Research Study Groups: Oral Vancomycin
Biliary Atresia Clinical Trial 2023: Vancomycin Highlights & Side Effects. Trial Name: NCT02137668 — Phase 1
Vancomycin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02137668 — Phase 1
~13 spots leftby Dec 2025
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