Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00760032

Enrollment

Registered

2008-09-25

Start date

Unknown

Completion date

Unknown

Last updated

2012-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascites, Cirrhosis, Infections

Keywords

Cirrhosis, Ascites, Lipopolysaccharide binding protein, Infections, Cytokines, Ciprofloxacin

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.

Interventions

DRUGCiprofloxacin

Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.

DRUGPlacebo

Placebo capsules, one capsule per day during four weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Lipopolysaccharide binding protein plasma levels	24 weeks

Secondary

Measure	Time frame
Severe infection	24 weeks
Pro- and anti-inflammatory cytokine secretion by PBMN cells	24 weeks

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026