Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

This study is currently recruiting participants.
Verified November 2012 by Region Skane
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Bengt Klarin, Region Skane
ClinicalTrials.gov Identifier:
NCT01521650
First received: January 26, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.

Healthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal but those do occur among patients, both in those not so sick and patients with more severe problems.

For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this is a pilot study to explore the possibility of the same kind of positive effects in patients due for longer (more than 4 hours of anesthesia) procedures.

Randomisation

  • No prophylaxis
  • Preparation with a probiotic suspension before intubation.

Cultures

  • oropharynx

    • before treatment
    • after intubation
    • before extubation
    • day 1 postoperatively
  • tracheal secretions

    • after intubation
    • before extubation

Condition Intervention
Oropharyngeal Microbiology
Dietary Supplement: Probiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Probiotics for Reduction of Colonisation With Pathogenic Bacteria in the Oropharynx in Connection With Anaesthesia

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Differences in pathogenic bacteria in the oropharynx and lower airways [ Time Frame: During hospitalization, up to 4 weeks ] [ Designated as safety issue: No ]
    Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in conection with anaestesia and a surgical intervention


Secondary Outcome Measures:
  • White blood cells [ Time Frame: During hospitalization, up to 4 weeks ] [ Designated as safety issue: No ]
    WBC taken pre-op and days 1,2,3 post-op

  • CRP [ Time Frame: During hospitalization, up to 4 weeks ] [ Designated as safety issue: No ]
    CRP taken pre-op and days 1,2,3 post-op

  • Pneumonia [ Time Frame: Up till 7 days postoperatively ] [ Designated as safety issue: No ]
    X-ray verified infiltrations in combination with expectorates

  • Length of hospital stay [ Time Frame: time to discharged from hospital or patients death ] [ Designated as safety issue: No ]
    Comparison of length of stay between the intervention group and the control group


Estimated Enrollment: 102
Study Start Date: January 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics
Patients will gurgle and swallow a mixture of probiotic bacteria
Dietary Supplement: Probiotics
Patients will gurgle and swallow a mixture of probiotic bacteria
Other Names:
  • Lactobacillus plantarum 299
  • +
  • Lactobacillus plantarum 299v
No Intervention: Control
No intervention. What has been the standard procedure so far

  Eligibility

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

Inclusion Criteria:

  • Adult patients
  • Planned interventions
  • Anaesthesia > 4 hours and requiring intubation

Exclusion Criteria:

  • Ulcers in the mouth, oropharynx, oesophagus and stomach
  • Current infections in the airways
  • Known immuno deficiences
  • Emergency cases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521650

Contacts
Contact: Bengt Klarin, MD PhD +4646171941 Bengt.Klarin@med.lu.se
Contact: Anne Adolfsson, RN +4646173805 anne.adolfsson@skane.se

Locations
Sweden
Lund University Hospital Recruiting
Lund, Sweden, SE-22185
Contact: Bengt Klarin, MD PhD    +4646171941    Bengt.Klarin@med.lu.se   
Contact: Anne Adolfsson, RN    +4646173805    anne.adolfsson@skane.se   
Sub-Investigator: Sofia Reimhagen, Med student         
Sponsors and Collaborators
Region Skane
Lund University
Investigators
Principal Investigator: Bengt klarin, MD PhD Lund University
  More Information

Publications:
Responsible Party: Bengt Klarin, MD Consultant, Region Skane
ClinicalTrials.gov Identifier: NCT01521650     History of Changes
Other Study ID Numbers: ProAnest
Study First Received: January 26, 2012
Last Updated: November 6, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Probiotics
Anaesthesia
Intubation
Pathogenic bacteria

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014