Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

NCT02605213 | Unknown Phase 4

• 1 other identifier: 9311366004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (1)

• Number of participants with adverse events

  12 weeks

Study Arms (2)

Vancomycin

EXPERIMENTAL

Vancomyicn 250 mg every 6 hours for 12 weeks

Drug: Vancomycin

Placebo

PLACEBO COMPARATOR

placebo every 6 hours for 12 weeks

Drug: Placebo

Interventions

Vancomycin DRUG

Vancomycin for treatment of primary sclerosing cholangitis

Also known as: Vancomycin hydrochloride,

Vancomycin

Placebo DRUG

Placebo for control Group of primary sclerosing vhlangitis

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• primary sclerosing chollangitis diagnosis more than 3 months
• inflammatory bowel disease with cholestasis diagnosis more than 3 months
• confirmed RCPM
• confirmed pathology of inflammatory bowel disease

You may not qualify if:

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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Imam khomeini Hospital Complex

Tehran, Tehran Province, 1419733141, Iran

RECRUITING

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Shahab Rahimpour, fellowship

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

Naser Ebrahimi Daryani, Professor

CONTACT

+989121104517; nasere@yahoo.com

Zahra Azizi, MD

CONTACT

+989121308409; zahra.azizi1990@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2015
• First Posted: November 16, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 16, 2015

Record last verified: 2015-11

Locations

IR (1)