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Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01521650
Recruitment Status : Active, not recruiting
First Posted : January 31, 2012
Last Update Posted : December 27, 2018
Lund University
Information provided by (Responsible Party):
Bengt Klarin, Region Skane

Brief Summary:

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 or disease Intervention/treatment Phase
Oropharyngeal Microbiology Dietary Supplement: Probiotics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
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
Study Start Date : January 2012
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. White blood cells [ Time Frame: During hospitalization, up to 4 weeks ]
    WBC taken pre-op and days 1,2,3 post-op

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

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

  4. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01521650

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Lund University Hospital
Lund, Sweden, SE-22185
Sponsors and Collaborators
Region Skane
Lund University
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Principal Investigator: Bengt klarin, MD PhD Lund University

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Responsible Party: Bengt Klarin, MD Consultant, Region Skane Identifier: NCT01521650     History of Changes
Other Study ID Numbers: ProAnest
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
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:
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Central Nervous System Depressants
Physiological Effects of Drugs