Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Region Skane
Lund University
Information provided by (Responsible Party):
Bengt Klarin, Region Skane Identifier:
First received: January 26, 2012
Last updated: October 26, 2015
Last verified: October 2015

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.


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


  • 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: December 2016
Estimated Primary Completion Date: June 2016 (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


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

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 identifier: NCT01521650

Contact: Bengt Klarin, MD PhD +4646171941
Contact: Anne Adolfsson, RN +4646173805

Lund University Hospital Recruiting
Lund, Sweden, SE-22185
Contact: Bengt Klarin, MD PhD    +4646171941   
Contact: Anne Adolfsson, RN    +4646173805   
Sub-Investigator: Sofia Reimhagen, Med student         
Sponsors and Collaborators
Region Skane
Lund University
Principal Investigator: Bengt klarin, MD PhD Lund University
  More Information

Responsible Party: Bengt Klarin, MD Consultant, Region Skane Identifier: NCT01521650     History of Changes
Other Study ID Numbers: ProAnest 
Study First Received: January 26, 2012
Last Updated: October 26, 2015
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Pathogenic bacteria

Additional relevant MeSH terms:
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 11, 2016