Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

• ClinicalTrials.gov Identifier: NCT02605213
• Recruitment Status: Unknown
• First Posted: November 16, 2015
• Last Update Posted: November 16, 2015
• Sponsor: Tehran University of Medical Sciences
• Information provided by (Responsible Party): Nasser Ebrahim Daryani, Tehran University of Medical Sciences

Tracking Information

• First Submitted Date: October 31, 2015
• First Posted Date: November 16, 2015
• Last Update Posted Date: November 16, 2015
• Study Start Date: September 2015
• Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 11, 2015)

• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 11, 2015)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
• Official Title: 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Primary Sclerosing Cholangitis

Intervention

• Drug: Vancomycin
  Vancomycin for treatment of primary sclerosing cholangitis
  Other Name: Vancomycin hydrochloride,
• Drug: Placebo
  Placebo for control Group of primary sclerosing vhlangitis

Study Arms

• Experimental: Vancomycin
  Vancomyicn 250 mg every 6 hours for 12 weeks
  Intervention: Drug: Vancomycin
• Placebo Comparator: Placebo
  placebo every 6 hours for 12 weeks
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 11, 2015): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2016
• Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. primary sclerosing chollangitis diagnosis more than 3 months
2. inflammatory bowel disease with cholestasis diagnosis more than 3 months
3. confirmed RCPM
4. confirmed pathology of inflammatory bowel disease

Exclusion Criteria:

1. signs of uncompensated cirrhosis like: hepatic encephalopathy, esophageal varices bleeding
2. gastrointestinal cancer or hepatic cancer
3. immunosuppressive agent using for hepatic problem (not vancomycine hypersensitivity)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT02605213
• Other Study ID Numbers: 9311366004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Nasser Ebrahim Daryani, Tehran University of Medical Sciences
• Study Sponsor: Tehran University of Medical Sciences
• Collaborators: Not Provided

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

• PRS Account: Tehran University of Medical Sciences
• Verification Date: November 2015