Ignite Creation Date:
2024-05-06 @ 7:47 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02605213
Status:
UNKNOWN
Last Update Posted:
2015-11-16
First Post:
2015-10-31
Brief Title:
Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
Evaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 flushingerythematous rash on face and upper body red neck or red man syndrome chills and drug fever eosinophilia and reversible neutropenia
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 flushingerythematous rash on face and upper body red neck or red man syndrome chills and drug fever eosinophilia and reversible neutropenia
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None