Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 September 11, 2014