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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02605213
Other study ID # 9311366004
Secondary ID
Status Recruiting
Phase Phase 4
First received October 31, 2015
Last updated November 11, 2015
Start date September 2015
Est. completion date February 2016

Study information

Verified date November 2015
Source Tehran University of Medical Sciences
Contact Naser Ebrahimi Daryani, Professor
Phone +989121104517
Email nasere@yahoo.com
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Vancomycin
Vancomycin for treatment of primary sclerosing cholangitis
Placebo
Placebo for control Group of primary sclerosing vhlangitis

Locations

Country Name City State
Iran, Islamic Republic of Imam khomeini Hospital Complex Tehran

Sponsors (1)

Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary comparison of laboratory data Alkalyne phosphatase between baseline and after treatment Alkaline phosphatase 12 weeks Yes
Primary comparison of laboratory data ALT between baseline and after treatment ALT 12 weeks Yes
Primary comparison of laboratory data AST between baseline and after treatment AST 12 weeks Yes
Primary comparison of laboratory data GGT between baseline and after treatment GGT 12 weeks Yes
Primary comparison of laboratory data serum total bilirubin between baseline and after treatment serum total bilirubin 12 weeks Yes
Primary baseline data serum Albumin baseline Yes
Secondary 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 Yes
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