Official Title: “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”

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.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

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

Primary Measures

• Lipopolysaccharide binding protein plasma levels
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• Severe infection
  • Time Frame: 24 weeks
    Safety Issue?: No
• Pro- and anti-inflammatory cytokine secretion by PBMN cells
  • Time Frame: 24 weeks
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Overall Clinical Trial Officials and Contacts

Florencia Vargas-Vorackova, M.D., Ph.D. Principal Investigator Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran  

Overall Contact: Felix I Tellez-Avila, M.D., M.Sc. (5255)5573-3418 felixtelleza@gmail.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00760032

Study ID Number: GAS-149-07-09-1

ClinicalTrials.gov Identifier: NCT00760032

Health Authority: Mexico: Ethics Committee

Sponsor's Web site