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Bovine Lactoferrin as a Natural Regimen of Selective Decontamination of the Digestive Tract in Patients With Prolonged Mechanical Ventilation

NCT01535170 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2012-02-17

No results posted yet for this study

Summary

Nosocomial infection with antibiotic-resistant strains is a major threat to critical care medicine. Selective decontamination of the digestive tract (SDD) is one of the strategies to reduce ventilator associated pneumonia and sepsis in critically ill patients. Lactoferrin (LF) is a natural multifunctional protein with antimicrobial, anti-tumor, antioxidant, and immunomodulatory effects. It has been shown to inhibit the growth of a number of pathogenic bacteria including antibiotic-resistant strains, fungi and even viruses in both in vitro and in vivo studies.

In a recent study, the investigators performed pathogen challenges of the digestive tract of a transgenic milk-fed animal model. The results showed that recombinant LF has broad spectrum antimicrobial activity in the digestive tract and protects the mucosa of the small intestine from injury, implying that LF can be used as an effective selective decontaminant of the digestive tract.

This study is a prospective, randomized, double-blind, placebo- controlled clinical trial examining whether oral supplementation with bLF can reduce nosocomial infection, sepsis and even mortality in patients with prolonged mechanical ventilation (MV). Patients with MV for more than 21 days and no signs of infection on admission to our Respiratory Care Center (RCC) will be enrolled. They will be randomized to receive either bovine LF (bLF, 10 mg/kg/day) or placebo for 6 weeks by center.

The primary objective is to evaluate the effectiveness of bLF in the prevention of nosocomial infection. Secondary objectives are assessment of incidence of nosocomial infection, mortality, weaning rate from MV and change of the immune system. The investigators hypothesize that bLF may 1) prevent nosocomial infection; 2) reduce mortality; 3)increase weaning rate from MV; 4)increase immunity in patients with prolonged MV.

Conditions

  • Nosocomial Infections

Interventions

DIETARY_SUPPLEMENT

bovine Lactoferrin

Patients will receive either bLF (10 mg/Kg/day) (Westland Co-operative Dairy Company, New Zealand) or placebo (starch) as control. The dosage of bLF is based on the mean hLF intake that very low body weight neonates ingest with mother's fresh milk in the first 2 weeks of life (30-150 mg/d) \[16\] and bLF 200 mg bid is found to be effective to suppress Helicobacter pylori \[17\].

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01535170 on ClinicalTrials.gov