Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02605213
Recruitment Status : Unknown
Verified November 2015 by Nasser Ebrahim Daryani, Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 16, 2015
Last Update Posted : November 16, 2015
Sponsor:
Information provided by (Responsible Party):
Nasser Ebrahim Daryani, Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE October 31, 2015
First Posted Date  ICMJE November 16, 2015
Last Update Posted Date November 16, 2015
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2015)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
Official Title  ICMJE Evaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis.
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Sclerosing Cholangitis
Intervention  ICMJE
  • Drug: Vancomycin
    Vancomycin for treatment of primary sclerosing cholangitis
    Other Name: Vancomycin hydrochloride,
  • Drug: Placebo
    Placebo for control Group of primary sclerosing vhlangitis
Study Arms  ICMJE
  • Experimental: Vancomycin
    Vancomyicn 250 mg every 6 hours for 12 weeks
    Intervention: Drug: Vancomycin
  • Placebo Comparator: Placebo
    placebo every 6 hours for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 11, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02605213
Other Study ID Numbers  ICMJE 9311366004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nasser Ebrahim Daryani, Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Tehran University of Medical Sciences
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP