Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
- Registration Number
- NCT02605213
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- primary sclerosing chollangitis diagnosis more than 3 months
- inflammatory bowel disease with cholestasis diagnosis more than 3 months
- confirmed RCPM
- confirmed pathology of inflammatory bowel disease
- signs of uncompensated cirrhosis like: hepatic encephalopathy, esophageal varices bleeding
- gastrointestinal cancer or hepatic cancer
- immunosuppressive agent using for hepatic problem (not vancomycine hypersensitivity)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo placebo every 6 hours for 12 weeks Vancomycin Vancomycin Vancomyicn 250 mg every 6 hours for 12 weeks
- Primary Outcome Measures
Name Time Method comparison of laboratory data serum total bilirubin between baseline and after treatment 12 weeks serum total bilirubin
comparison of laboratory data GGT between baseline and after treatment 12 weeks GGT
baseline data baseline serum Albumin
comparison of laboratory data Alkalyne phosphatase between baseline and after treatment 12 weeks Alkaline phosphatase
comparison of laboratory data AST between baseline and after treatment 12 weeks AST
comparison of laboratory data ALT between baseline and after treatment 12 weeks ALT
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events 12 weeks 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.
Trial Locations
- Locations (1)
Imam khomeini Hospital Complex
🇮🇷Tehran, Iran, Islamic Republic of