Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: Placebo; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02605213

9311366004

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. primary sclerosing chollangitis diagnosis more than 3 months
2. inflammatory bowel disease with cholestasis diagnosis more than 3 months
3. confirmed RCPM
4. confirmed pathology of inflammatory bowel disease

Exclusion criteria

1. signs of uncompensated cirrhosis like: hepatic encephalopathy, esophageal varices bleeding
2. gastrointestinal cancer or hepatic cancer
3. immunosuppressive agent using for hepatic problem (not vancomycine hypersensitivity)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Vancomycin

Experimental group

Description:

Vancomyicn 250 mg every 6 hours for 12 weeks

Treatment:

Drug: Vancomycin

Placebo

Placebo Comparator group

Description:

placebo every 6 hours for 12 weeks

Treatment:

Drug: Placebo