A Phase 1 interventional study of Oral Vancomycin in Primary Sclerosing Cholangitis and Biliary Atresia, sponsored by Sacramento Pediatric Gastroenterology. Recruiting at 1 site in United States. Open to participants aged 2 Weeks to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-15.
Sponsored by Sacramento Pediatric Gastroenterology · Phase 1, Interventional, and Treatment
Among 12 studies testing vancomycin in Cholangitis, Sclerosing — 5 open to participants now, 5 under way, none of them phase 3. Vancomycin · Cholangitis, Sclerosing.
Among the 12 studies testing vancomycin in Cholangitis, Sclerosing, this one has the largest planned enrollment, is one of 2 that started in 2010, is one of 5 in phase 1, and was the 4th registered.
149 studies on the registry are indexed under Cholangitis, Sclerosing; 39 are open to participants now.
This study's planned enrollment of 200 is above the median of 34 across 94 interventional studies indexed under Cholangitis, Sclerosing.
Browse Cholangitis, Sclerosing studies →5 of the 12 studies testing vancomycin in Cholangitis, Sclerosing are open now, in 4 countries. Each count lists the studies.
Vancomycin: first FDA approval 1964 (VANCOCIN HYDROCHLORIDE). What it is approved for, and how studies give it, is on its page →
Of the 30 Cholangitis, Sclerosing studies recruiting now, 12 (40%) set no upper age limit and 13 (43%) stop at 75 or younger; 9 take children under 18; 9 take healthy volunteers.
This study: 2 Weeks to 40 Years · all sexes · healthy volunteers too.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2010.
Median enrollment 33 across the 12 interventional studies. Of the 5 that completed or were terminated, 4 (80%) have results posted.
None of the 12 has an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Sacramento Pediatric Gastroenterology as lead sponsor.
Sacramento Pediatric Gastroenterology has 1 study filed under Cholangitis, Sclerosing — fewer than ten, so there is no comparison to draw.
1 of the studies testing vancomycin in Cholangitis, Sclerosing that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06197308University of MinnesotaEvaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC | 2027-03-31 |
Among the 12 studies testing vancomycin in Cholangitis, Sclerosing, from their registry updates:
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.
Investigators hope to learn to characterize human intestinal microbial communities (microbiome: the collection or collectivity of microorganisms) using molecular methods, examine the mechanisms of interaction between host and microbiome using genomic approaches, and determine how the microbiome both preserves local health and promotes pathology. Investigation will focus on primary sclerosing cholangitis, biliary atresia, as well as states of health. The composition of the associated microbiome will be assessed based on ribosomal DNA and RNA sequences, and attention will be given to richness (diversity), evenness (relative abundance), and variation with respect to time, person, and anatomic niche. Host response at the adjacent mucosal surface will be assessed based on genome-wide gene expression patterns. In addition, changes in the metabolites of the blood will be analyzed.
To see if the antibiotic vancomycin, when used for the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC) is effective treatment for these diseases. Investigators hope to learn what effect Vancomycin has on the bacteria that are present in stool, body fluid or intestinal tissue on someone who has BA and PSC and if so by what mechanism.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Every participant with PSC or BA will received the same Arm of Oral Vancomycin
Drug: Oral Vancomycin
Oral Vancomycin is given to PSC or BA participants
Also known as: ANI
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia
Blood tests, imaging studies and/or liver biopsy changes before and while on oral vancomycin will determine the benefit of the treatment.
Time frame: 3 months
Plan to share: Yes — Data collected throughout study and will be shared via publications when available at certain time points.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Vancomycin