Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis.

Conditions
-----------------
Primary Sclerosing Cholangitis

Intervention / Treatment
-----------------
* Drug: Vancomycin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: signs of uncompensated cirrhosis like: hepatic encephalopathy, esophageal varices bleeding gastrointestinal cancer or hepatic cancer immunosuppressive agent using for hepatic problem (not vancomycine hypersensitivity)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vancomycin<br>Vancomyicn 250 mg every 6 hours for 12 weeks | Drug: Vancomycin<br>* Vancomycin for treatment of primary sclerosing cholangitis<br>* Other names: Vancomycin hydrochloride,;|
| Placebo Comparator: Placebo<br>placebo every 6 hours for 12 weeks | Drug: Placebo<br>* Placebo for control Group of primary sclerosing vhlangitis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of laboratory data Alkalyne phosphatase between baseline and after treatment | Alkaline phosphatase | 12 weeks | 
| comparison of laboratory data ALT between baseline and after treatment | ALT | 12 weeks | 
| comparison of laboratory data AST between baseline and after treatment | AST | 12 weeks | 
| comparison of laboratory data GGT between baseline and after treatment | GGT | 12 weeks | 
| comparison of laboratory data serum total bilirubin between baseline and after treatment | serum total bilirubin | 12 weeks | 
| baseline data | serum Albumin | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | 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. | 12 weeks |