Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
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|ClinicalTrials.gov Identifier: NCT02605213|
Recruitment Status : Unknown
Verified November 2015 by Nasser Ebrahim Daryani, Tehran University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : November 16, 2015
Last Update Posted : November 16, 2015
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|
|Primary Sclerosing Cholangitis||Drug: Vancomycin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis.|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||February 2016|
Vancomyicn 250 mg every 6 hours for 12 weeks
Vancomycin for treatment of primary sclerosing cholangitis
Other Name: Vancomycin hydrochloride,
Placebo Comparator: Placebo
placebo every 6 hours for 12 weeks
Placebo for control Group of primary sclerosing vhlangitis
- comparison of laboratory data Alkalyne phosphatase between baseline and after treatment [ Time Frame: 12 weeks ]Alkaline phosphatase
- comparison of laboratory data ALT between baseline and after treatment [ Time Frame: 12 weeks ]ALT
- comparison of laboratory data AST between baseline and after treatment [ Time Frame: 12 weeks ]AST
- comparison of laboratory data GGT between baseline and after treatment [ Time Frame: 12 weeks ]GGT
- comparison of laboratory data serum total bilirubin between baseline and after treatment [ Time Frame: 12 weeks ]serum total bilirubin
- baseline data [ Time Frame: baseline ]serum Albumin
- Number of participants with adverse events [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605213
|Contact: Naser Ebrahimi Daryani, Professorfirstname.lastname@example.org|
|Contact: Zahra Azizi, MDemail@example.com|
|Iran, Islamic Republic of|
|Imam khomeini Hospital Complex||Recruiting|
|Tehran, Iran, Islamic Republic of, 1419733141|
|Contact: Naser Ebrahimi Daryani, Professor +989121104517 firstname.lastname@example.org|
|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|