Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Sclerosing Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vancomycin

Vancomyicn 250 mg every 6 hours for 12 weeks

Group Type EXPERIMENTAL

Vancomycin

Intervention Type DRUG

Vancomycin for treatment of primary sclerosing cholangitis

Placebo

placebo every 6 hours for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for control Group of primary sclerosing vhlangitis

Interventions

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Vancomycin

Vancomycin for treatment of primary sclerosing cholangitis

Intervention Type DRUG

Placebo

Placebo for control Group of primary sclerosing vhlangitis

Intervention Type DRUG

Other Intervention Names

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Vancomycin hydrochloride,

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Nasser Ebrahim Daryani

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR