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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have a liver or intestinal condition, or I'm getting an endoscopy.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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

Frequently Asked Questions

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

Who is eligible to participate in this medical research project?

"Individuals with biliary atresia that are between 2 Weeks and 40 years old may be eligible for this medical trial. Up to two hundred participants can join the experiment."

Answered by AI

Has the FDA sanctioned Oral Vancomycin for therapeutic usage?

"The safety of Oral Vancomycin is estimated to rank at a 1 on the scale due to its limited clinical data regarding efficacy and safety."

Answered by AI

Are there any opportunities for individuals to enroll in this research project?

"According to the information present on clinicaltrials.gov, this study is currently recruiting participants and was initially posted in July of 2010 with its most recent edit occurring November 2016."

Answered by AI

Have other investigations included Oral Vancomycin as part of their research?

"Currently, 55 clinical trials exploring Oral Vancomycin are ongoing. Of that figure, 6 of those investigations have reached Phase 3. Jupiter, Florida is the primary location for these studies; however, there are 315 medical sites conducting research on this medication."

Answered by AI

Are elderly individuals being recruited for the experiment?

"This medical trial only allows those between 2 Weeks and 40 years old to apply. There are 24 studies that cater to minors, while 87 of them target geriatric patients."

Answered by AI

How many participants have been recruited to join this clinical trial?

"Absolutely. According to clinicaltrials.gov, this medical study is taking on new participants from a single site and has been recruiting since July 1st 2010. The trial was recently updated on November 10th 2016 and is calling for 200 total enrollees."

Answered by AI

What medical conditions is Oral Vancomycin typically prescribed to treat?

"Oral Vancomycin has been found effective in treating staphylococcal infections, staphylococci-induced infection, and enterocolitis caused by Staphylococcus aureus."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
2010. "Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02137668.
~14 spots leftby Apr 2025
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