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Open pilot study of treatment with an antibiotic called vancomycin to children and adolescents with chronic inflammation of the bile ducts, called primary sclerosing cholangitis (PSC)

Open pilot study of treatment with vancomycin to children and adolescents with primary sclerosing cholangitis - vanco-psc

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-018034-11-SE
Enrollment
20
Registered
2011-06-21
Start date
2013-04-29
Completion date
Unknown
Last updated
2013-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sclerosing Cholangitis (PSC) is a progressive disease of the biliary system which might lead to increased risk of cholangiocancer. PSC constitutes a common indication for adult liver transplantation (ltx). In 80% of cases PSC is associated with inflammatory bowel disease (IBD), while 3-5 % of patients with colonic IBD, suffer from the disease. The conservative treatment options are few. There is a relatively high risk of recurrency after ltx.

Interventions

Trade Name: Vancomycin Product Name: vancomycin Pharmaceutical Form: Capsule Trade Name: vancomycin Product Name: Vancomycin Pharmaceutical Form: Oral solution

Sponsors

Karolinska Institutet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children and adolescents > 1 year =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known hypersensitivity towards vancomycin Pregnancy Chronic renal failure.

Design outcomes

Primary

MeasureTime frame
Main Objective: To study if oral vancomycin during 1 year may improve liver- and gut function. ;Secondary Objective: To study if oral vancomycin during 1 year may improve liver histology and magnetic resonance cholangiography (MRC);Primary end point(s): Clinical status of patients after 1 year Improvement of symptoms after 1 year Improvement of liver function tests after 1 year Improvement of bile duct stenosis as measured by MRC after 1 year Improvement of liver histology after 1 year;Timepoint(s) of evaluation of this end point: One year after treatment start

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026