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
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Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | October 31, 2015 | ||||||||||||||||||
First Posted Date ICMJE | November 16, 2015 | ||||||||||||||||||
Last Update Posted Date | November 16, 2015 | ||||||||||||||||||
Study Start Date ICMJE | September 2015 | ||||||||||||||||||
Estimated Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | No Changes Posted | ||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients | ||||||||||||||||||
Official Title ICMJE | Evaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis. | ||||||||||||||||||
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. |
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Detailed Description | Not Provided | ||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Phase 4 | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Primary Sclerosing Cholangitis | ||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Unknown status | ||||||||||||||||||
Estimated Enrollment ICMJE |
30 | ||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
Estimated Study Completion Date ICMJE | February 2016 | ||||||||||||||||||
Estimated Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | Iran, Islamic Republic of | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT02605213 | ||||||||||||||||||
Other Study ID Numbers ICMJE | 9311366004 | ||||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||||||||||||
Responsible Party | Nasser Ebrahim Daryani, Tehran University of Medical Sciences | ||||||||||||||||||
Study Sponsor ICMJE | Tehran University of Medical Sciences | ||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | Tehran University of Medical Sciences | ||||||||||||||||||
Verification Date | November 2015 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |