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Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

Primary Purpose

Primary Sclerosing Cholangitis

Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vancomycin
Placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Imam khomeini Hospital ComplexRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vancomycin

Placebo

Arm Description

Vancomyicn 250 mg every 6 hours for 12 weeks

placebo every 6 hours for 12 weeks

Outcomes

Primary Outcome Measures

comparison of laboratory data Alkalyne phosphatase between baseline and after treatment
Alkaline phosphatase
comparison of laboratory data ALT between baseline and after treatment
ALT
comparison of laboratory data AST between baseline and after treatment
AST
comparison of laboratory data GGT between baseline and after treatment
GGT
comparison of laboratory data serum total bilirubin between baseline and after treatment
serum total bilirubin
baseline data
serum Albumin

Secondary Outcome Measures

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.

Full Information

First Posted
October 31, 2015
Last Updated
November 11, 2015
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02605213
Brief Title
Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
Official Title
Evaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin
Arm Type
Experimental
Arm Description
Vancomyicn 250 mg every 6 hours for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo every 6 hours for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
Vancomycin hydrochloride,
Intervention Description
Vancomycin for treatment of primary sclerosing cholangitis
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for control Group of primary sclerosing vhlangitis
Primary Outcome Measure Information:
Title
comparison of laboratory data Alkalyne phosphatase between baseline and after treatment
Description
Alkaline phosphatase
Time Frame
12 weeks
Title
comparison of laboratory data ALT between baseline and after treatment
Description
ALT
Time Frame
12 weeks
Title
comparison of laboratory data AST between baseline and after treatment
Description
AST
Time Frame
12 weeks
Title
comparison of laboratory data GGT between baseline and after treatment
Description
GGT
Time Frame
12 weeks
Title
comparison of laboratory data serum total bilirubin between baseline and after treatment
Description
serum total bilirubin
Time Frame
12 weeks
Title
baseline data
Description
serum Albumin
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary sclerosing chollangitis diagnosis more than 3 months inflammatory bowel disease with cholestasis diagnosis more than 3 months confirmed RCPM confirmed pathology of inflammatory bowel disease Exclusion Criteria: signs of uncompensated cirrhosis like: hepatic encephalopathy, esophageal varices bleeding gastrointestinal cancer or hepatic cancer immunosuppressive agent using for hepatic problem (not vancomycine hypersensitivity)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naser Ebrahimi Daryani, Professor
Phone
+989121104517
Email
nasere@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zahra Azizi, MD
Phone
+989121308409
Email
zahra.azizi1990@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahab Rahimpour, fellowship
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Kazem NouriTaromlou, M.D.
Organizational Affiliation
Tehran UMS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Naser Ebrahimi Daryani, Professor
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sanam Javidanbardan, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zahra Azizi, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohsen Nasiri Toosi, Professor
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Imam khomeini Hospital Complex
City
Tehran
ZIP/Postal Code
1419733141
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naser Ebrahimi Daryani, Professor
Phone
+989121104517
Email
nasere@yahoo.com

12. IPD Sharing Statement

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Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

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