Clinical trial NCT02605213: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Primary Sclerosing Cholangitis
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: comparison of laboratory data Alkalyne phosphatase between baseline and after treatment
timeFrame: 12 weeks
measure: comparison of laboratory data ALT between baseline and after treatment
timeFrame: 12 weeks
measure: comparison of laboratory data AST between baseline and after treatment
timeFrame: 12 weeks
measure: comparison of laboratory data GGT between baseline and after treatment
timeFrame: 12 weeks
measure: comparison of laboratory data serum total bilirubin between baseline and after treatment
timeFrame: 12 weeks
measure: baseline data
timeFrame: baseline
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam khomeini Hospital Complex
Study officials:
affiliation: Tehran University of Medical Sciences
name: Shahab Rahimpour, fellowship
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran UMS
name: Mohammad Kazem NouriTaromlou, M.D.
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Naser Ebrahimi Daryani, Professor
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Sanam Javidanbardan, M.D.
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Zahra Azizi, M.D.
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Mohsen Nasiri Toosi, Professor
role: STUDY_DIRECTOR
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