Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
Status:
Unknown status
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
Primary sclerotic cholangitis (PSC) is an inflammatory process of sclerotic cholangitis that
involves intra and extra hepatic biliary system. There is no curative treatment for this
disorder. Supportive and conservative treatments are the most common therapies that used for
this disease. Although treatments such as ursodeoxycholic acid (UDCA) are recommended in some
situations but whereas a hypothesis is stimulatory effect of intestinal anaerobic bacteria
such as cholestridium difficile as pathogenesıs of PSC, so use of antibiotics is recommended
for treatment of these patients. Therefore according to the great role of anaerobic bacteria
such as cholestridium difficile in pathogenesis, antibiotics such as metronidazole and
vancomycin can be counted as recommended therapies in PSC. In addition some studies
correlated this effect of vancomycin to its immunomudulatory effect the cause reduction of
inflammation in biliary system. But with all this detail there is no finality about
effectiveness of antibiotic therapy and accordingly in this study the investigators compare
oral vancomycin effect versus placebo in primary sclerosing cholangitis patients.
In this double blind clinical trial 30 primary sclerosing cholangitis patients that divided
in two 15 persosns group with Block Randomization method. in this study one group receive 250
mg oral vancomycin every 6 hours and other group receive placebo.
The study duration is 12 weeks . The baseline laboratory tests and 1 month and 3 months after
treatment concept of; Alkaline phosphatase, ALT, AST, GGT and serum total bilirubin and
clinical manifestations such as tiredness, itching and probable adverse effects such as
hypotension accompanied by flushing,erythematous rash on face and upper body (red neck or red
man syndrome), chills and drug fever, eosinophilia and reversible neutropenia.