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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01535170
First received: June 15, 2011
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Nosocomial Infections
Dietary Supplement: bovine Lactoferrin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Bovine Lactoferrin as a Natural Regimen of Selective Decontamination of the Digestive Tract in Patients With Prolonged Mechanical Ventilation

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Prevention of infection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    To evaluate the effectiveness of bLF in the prevention of the first episode of nosocomial infection and sepsis


Secondary Outcome Measures:
  • Effects on infection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    assessments of the incidence of pneumonia, urinary tract infection.

  • Effects on immunity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    alteration of immune system, cytokines


Estimated Enrollment: 280
Study Start Date: September 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bovine Lactoferrin

Lactoferrin and placebo will be masked as drug A and B in the factory. Randomization will be stratified by center and patients will be randomized into A or B groups by a random-number table sequence after informed consents are obtained. No patients, research nurses, investigators, or other medical staffs in RCC will be aware of the assignment during the study period.

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]. Drug administration will begin within 24 hours after RCC admission and will last for 6 weeks or until discharge. Medication and nutritional support will be prescribed as the medical routine.

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].
Placebo Comparator: Placebo
Patients will receive either bLF (10 mg/Kg/day) (Westland Co-operative Dairy Company, New Zealand) or placebo (starch) as control.
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].

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with mechanical ventilation for more than 21 days and no evident signs of infection in our Respiratory Care Center (RCC).

Exclusion Criteria:

  1. Informed consent lacking/refused
  2. Ongoing antibiotics treatment for infection
  3. Predicted mortality in 7 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535170

Contacts
Contact: Chih-Ching Yen, MD, PhD 886-4-22-52121 ext 3483 D5210@mail.cmuh.org.tw

Locations
Taiwan
Department of Internal Medicine, China Medical Univdersity Hospital Recruiting
Taichung, Taiwan
Contact: Chih-Chihng Yen, MD, PhD    886-4-22052121 ext 3483    d5210@mail.cmuh.org.tw   
Principal Investigator: Chih-Ching Yen, MD, PhD         
Sponsors and Collaborators
China Medical University Hospital
  More Information

Publications:

Responsible Party: Deapartment of Medical Research, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01535170     History of Changes
Other Study ID Numbers: DMR99-IRB-076
Study First Received: June 15, 2011
Last Updated: February 14, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by China Medical University Hospital:
lactoferrin
selective decontamination of digestive tract
antimicrobial activity
prolonged mechanical ventilation
respiratory care center

Additional relevant MeSH terms:
Cross Infection
Infection
Lactoferrin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014