Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

Overview

The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well as with the development of severe infectious events in cirrhotic patients with ascites. As a secondary purpose, the study will evaluate the effect of a prophylactic administration of ciprofloxacin on LBP, cytokines and infections in the same patients.

Full Title of Study: “Association of Serum Levels of Lipopolysaccharide Binding Protein (LBP) With the Evolution of Pro- and Anti-inflammatory Cytokines, and the Development of Severe Infectious Events in Cirrhotic Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Care Provider)

Interventions

  • Drug: Ciprofloxacin
    • Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.
  • Drug: Placebo
    • Placebo capsules, one capsule per day during four weeks.

Arms, Groups and Cohorts

  • Experimental: Active
    • Ciprofloxacin
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Lipopolysaccharide binding protein plasma levels
    • Time Frame: 24 weeks

Secondary Measures

  • Severe infection
    • Time Frame: 24 weeks
  • Pro- and anti-inflammatory cytokine secretion by PBMN cells
    • Time Frame: 24 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Cirrhosis
  • Ascites
  • No history of spontaneous bacterial peritonitis and/or < 1 g of protein in ascites
  • No antibiotic use in previous 6 weeks
  • Absence of infection (documented by clinical history, blood cytology, urinalysis and urine culture, thorax x-ray and paracentesis)
  • Absence of GI bleeding or encephalopathy
  • Signature of informed consent

Exclusion Criteria

  • Ciprofloxacin contraindication
  • Autoimmune hepatitis, sclerosing cholangitis or other autoimmune disease
  • > 13 Child-Pugh points
  • Inability to attend to regular visits
  • Current alcohol intake
  • Terminal disease with < 24 week expected survival

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Florencia Vargas-Vorackova
  • Collaborator
    • Laboratorios Senosiain, S.A. de C.V.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Florencia Vargas-Vorackova, Doctor – Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Overall Official(s)
    • Florencia Vargas-Vorackova, M.D., Ph.D., Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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