Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
Phase 1 · Testing Oral Vancomycin · 1 site · Sacramento Pediatric Gastroenterology
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Oral Vancomycin (a drug) as a possible treatment. Condition(s) listed: Primary Sclerosing Cholangitis and Biliary Atresia.
It is open-label: participants know what they are receiving.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 2 Weeks to 40
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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.
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- The study has 1 group.
- Start date: 2010-07.
- Main results expected around 2018-05 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Oral Vancomycin (listed as: experimental group)
Main thing being measured
- Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia (3 months)
In the researchers’ words
The purpose of this study is twofold. First, is to determine whether vancomycin is effective in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and if so, by what mechanism. Secondly, to characterize human intestinal microbial communities and their interactions with the host.
Words you might see
- Endoscopy: a camera exam inside the digestive tract.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Primary Sclerosing Cholangitis; Biliary Atresia |
| Lead sponsor | Sacramento Pediatric Gastroenterology |
| Enrollment | 200 (estimated) |
| Start date | 2010-07 |
| Primary completion (est.) | 2018-05 |
| First posted | 2014-05-14 |
| Last updated | 2016-11-15 |
| Official title | The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin |
| ClinicalTrials.gov ID | NCT02137668 |
Interventions
- Oral Vancomycin (Drug)
Oral Vancomycin is given to PSC or BA participants
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Sacramento Pediatric Gastroenterology | Sacramento, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.