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Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Nasser Ebrahim Daryani, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02605213
First received: October 31, 2015
Last updated: November 11, 2015
Last verified: November 2015
  Purpose

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.


Condition Intervention Phase
Primary Sclerosing Cholangitis
Drug: Vancomycin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis.

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • comparison of laboratory data Alkalyne phosphatase between baseline and after treatment [ Time Frame: 12 weeks ]
    Alkaline phosphatase

  • comparison of laboratory data ALT between baseline and after treatment [ Time Frame: 12 weeks ]
    ALT

  • comparison of laboratory data AST between baseline and after treatment [ Time Frame: 12 weeks ]
    AST

  • comparison of laboratory data GGT between baseline and after treatment [ Time Frame: 12 weeks ]
    GGT

  • comparison of laboratory data serum total bilirubin between baseline and after treatment [ Time Frame: 12 weeks ]
    serum total bilirubin

  • baseline data [ Time Frame: baseline ]
    serum Albumin


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 12 weeks ]
    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.


Estimated Enrollment: 30
Study Start Date: September 2015
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vancomycin
Vancomyicn 250 mg every 6 hours for 12 weeks
Drug: Vancomycin
Vancomycin for treatment of primary sclerosing cholangitis
Other Name: Vancomycin hydrochloride,
Placebo Comparator: Placebo
placebo every 6 hours for 12 weeks
Drug: Placebo
Placebo for control Group of primary sclerosing vhlangitis

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02605213

Contacts
Contact: Naser Ebrahimi Daryani, Professor +989121104517 nasere@yahoo.com
Contact: Zahra Azizi, MD +989121308409 zahra.azizi1990@gmail.com

Locations
Iran, Islamic Republic of
Imam khomeini Hospital Complex Recruiting
Tehran, Iran, Islamic Republic of, 1419733141
Contact: Naser Ebrahimi Daryani, Professor    +989121104517    nasere@yahoo.com   
Sponsors and Collaborators
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
  More Information

Responsible Party: Nasser Ebrahim Daryani, Professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02605213     History of Changes
Other Study ID Numbers: 9311366004
Study First Received: October 31, 2015
Last Updated: November 11, 2015

Additional relevant MeSH terms:
Cholangitis, Sclerosing
Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2017