Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

Primary Sclerosing Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02605213
• Other study ID #: 9311366004
• 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

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

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