Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Primary Sclerosing Cholangitis
• Intervention / Treatment: Drug: Vancomycin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Naser Ebrahimi Daryani, Professor; Phone Number: +989121104517; Email: nasere@yahoo.com
• Study Contact Backup: Name: Zahra Azizi, MD; Phone Number: +989121308409; Email: zahra.azizi1990@gmail.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1419733141
    • Recruiting
    • Imam Khomeini Hospital Complex
    • Contact: Naser Ebrahimi Daryani, Professor; Phone Number: +989121104517; Email: nasere@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Principal Investigator: Shahab Rahimpour, fellowship, Tehran University Of Medical Sciences; Study Director: Mohammad Kazem NouriTaromlou, M.D., Tehran UMS; Study Director: Naser Ebrahimi Daryani, Professor, Tehran University Of Medical Sciences; Study Director: Sanam Javidanbardan, M.D., Tehran University Of Medical Sciences; Study Director: Zahra Azizi, M.D., Tehran University Of Medical Sciences; Study Director: Mohsen Nasiri Toosi, Professor, Tehran University Of Medical Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: October 31, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Estimate): November 16, 2015
• Last Update Submitted That Met QC Criteria: November 11, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholangitis; Cholangitis, Sclerosing; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 9311366004