Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin | Experimental | Vancomyicn 250 mg every 6 hours for 12 weeks |
|
| Placebo | Placebo Comparator | placebo every 6 hours for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | Vancomycin for treatment of primary sclerosing cholangitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| comparison of laboratory data Alkalyne phosphatase between baseline and after treatment | Alkaline phosphatase | 12 weeks |
| comparison of laboratory data ALT between baseline and after treatment | ALT | 12 weeks |
| comparison of laboratory data AST between baseline and after treatment | AST | 12 weeks |
| comparison of laboratory data GGT between baseline and after treatment | GGT | 12 weeks |
| comparison of laboratory data serum total bilirubin between baseline and after treatment | serum total bilirubin | 12 weeks |
| baseline data | serum Albumin | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naser Ebrahimi Daryani, Professor | Contact | +989121104517 | nasere@yahoo.com | |
| Zahra Azizi, MD | Contact | +989121308409 | zahra.azizi1990@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shahab Rahimpour, fellowship | Tehran University of Medical Sciences | Principal Investigator |
| Mohammad Kazem NouriTaromlou, M.D. | Tehran UMS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imam khomeini Hospital Complex | Recruiting | Tehran | Tehran Province | 1419733141 | Iran |
Not provided
| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo for control Group of primary sclerosing vhlangitis |
|
| 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 Director |
| D000602 |
| Amino Acids, Peptides, and Proteins |