Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

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.

Conditions

• Primary Sclerosing Cholangitis

Interventions

DRUG

Vancomycin

Vancomycin for treatment of primary sclerosing cholangitis

DRUG

Placebo

Placebo for control Group of primary sclerosing vhlangitis

Sponsors & Collaborators

• Tehran University of Medical Sciences

  lead OTHER

Principal Investigators

• Shahab Rahimpour, fellowship · Tehran University of Medical Sciences

• Mohammad Kazem NouriTaromlou, M.D. · Tehran UMS

• Naser Ebrahimi Daryani, Professor · Tehran University of Medical Sciences

• Sanam Javidanbardan, M.D. · Tehran University of Medical Sciences

• Zahra Azizi, M.D. · Tehran University of Medical Sciences

• Mohsen Nasiri Toosi, Professor · Tehran University of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2016-02-29

Completion

2016-02-29

Countries

• Iran

Study Locations