This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Bengt Klarin, Region Skane
Lund University
Information provided by (Responsible Party):
Bengt Klarin, Region Skane Identifier:
First received: January 26, 2012
Last updated: April 10, 2017
Last verified: April 2017

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
Intervention Model: Parallel Assignment
Masking: None (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 Bengt Klarin, Region Skane:

Primary Outcome Measures:
  • Differences in pathogenic bacteria in the oropharynx and lower airways [ Time Frame: During hospitalization, up to 4 weeks ]
    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 ]
    WBC taken pre-op and days 1,2,3 post-op

  • CRP [ Time Frame: During hospitalization, up to 4 weeks ]
    CRP taken pre-op and days 1,2,3 post-op

  • Pneumonia [ Time Frame: Up till 7 days postoperatively ]
    X-ray verified infiltrations in combination with expectorates

  • Length of hospital stay [ Time Frame: time to discharged from hospital or patients death ]
    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 2017
Estimated Primary Completion Date: August 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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: April 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results are intended to be published in a scientific journal

Keywords provided by Bengt Klarin, Region Skane:
Pathogenic bacteria

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on September 19, 2017