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Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00760032
Recruitment Status : Withdrawn (was not possible to measure LBP levels because we cannot found the kit)
First Posted : September 25, 2008
Last Update Posted : December 5, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cirrhosis Ascites Infections Drug: Ciprofloxacin Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Active
Ciprofloxacin
Drug: Ciprofloxacin
Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.
Other Name: Ciproflox
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo capsules, one capsule per day during four weeks.


Outcome Measures

Primary Outcome Measures :
  1. Lipopolysaccharide binding protein plasma levels [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Severe infection [ Time Frame: 24 weeks ]
  2. Pro- and anti-inflammatory cytokine secretion by PBMN cells [ Time Frame: 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760032


Locations
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico, D.f., Mexico, 14000
Sponsors and Collaborators
Florencia Vargas-Vorackova
Laboratorios Senosiain, S.A. de C.V.
Investigators
Principal Investigator: Florencia Vargas-Vorackova, M.D., Ph.D. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
More Information

Additional Information:
Responsible Party: Florencia Vargas-Vorackova, Doctor, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT00760032     History of Changes
Other Study ID Numbers: GAS-149-07-09-1
REF. 1612
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012

Keywords provided by Florencia Vargas-Vorackova, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Cirrhosis
Ascites
Lipopolysaccharide binding protein
Infections
Cytokines
Ciprofloxacin

Additional relevant MeSH terms:
Fibrosis
Ascites
Pathologic Processes
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors