Using vancomycin to treat Primary Sclerosing Cholangitis and Biliary Atresia
The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
PHASE1 · Sacramento Pediatric Gastroenterology · NCT02137668
This study is testing if the antibiotic vancomycin can help improve the health of people with Biliary Atresia and Primary Sclerosing Cholangitis while also looking at how it affects the gut bacteria.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 2 Weeks to 40 Years |
| Sex | All |
| Sponsor | Sacramento Pediatric Gastroenterology (other) |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT02137668 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of vancomycin in treating Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC) while also characterizing the human intestinal microbiome. Researchers will utilize molecular methods to analyze the microbiome's composition and its interactions with the host, focusing on how these factors influence health and disease. The study will assess changes in microbial communities, host gene expression, and blood metabolites in response to vancomycin treatment. The goal is to understand the mechanisms by which vancomycin may affect these conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Primary Sclerosing Cholangitis or Biliary Atresia who are suitable for vancomycin therapy.
Not a fit: Patients who have taken antibiotics or immunomodulators in the last three months or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Biliary Atresia and Primary Sclerosing Cholangitis.
How similar studies have performed: While the approach of using vancomycin in this context is novel, similar studies exploring the microbiome's role in disease have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persons who have primary sclerosing cholangitis, biliary atresia, a chronic intestinal disorder or who are undergoing upper or lower endoscopy. * Persons who have primary sclerosing cholangitis or biliary atresia who are good candidates for vancomycin therapy. Exclusion Criteria: * 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.
Where this trial is running
Sacramento, California
- Sacramento Pediatric Gastroenterology — Sacramento, California, United States (RECRUITING)
Study contacts
- Principal investigator: Yinka Davies, M.D. — Sacramento Pediatric Gastroenterology
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Sclerosing Cholangitis, Biliary Atresia