Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vancomycin Vancomyicn 250 mg every 6 hours for 12 weeks |
Drug: Vancomycin
Vancomycin for treatment of primary sclerosing cholangitis
Other Names:
|
| Placebo Comparator: Placebo placebo every 6 hours for 12 weeks |
Drug: Placebo
Placebo for control Group of primary sclerosing vhlangitis
|
Outcome Measures
Primary Outcome Measures
- comparison of laboratory data Alkalyne phosphatase between baseline and after treatment [12 weeks]
Alkaline phosphatase
- comparison of laboratory data ALT between baseline and after treatment [12 weeks]
ALT
- comparison of laboratory data AST between baseline and after treatment [12 weeks]
AST
- comparison of laboratory data GGT between baseline and after treatment [12 weeks]
GGT
- comparison of laboratory data serum total bilirubin between baseline and after treatment [12 weeks]
serum total bilirubin
- baseline data [baseline]
serum Albumin
Secondary Outcome Measures
- Number of participants with adverse events [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.
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Imam khomeini Hospital Complex | Tehran | Iran, Islamic Republic of | 1419733141 |
Sponsors and Collaborators
- Tehran University of Medical Sciences
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 9311366004