Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

Probiotics for Reduction of Colonisation With Pathogenic Bacteria in the Oropharynx in Connection With Anaesthesia

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

Study Overview

• Status: Completed
• Conditions: Oropharyngeal Microbiology
• Intervention / Treatment: Dietary supplement: Probiotics

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-22185
    • Lund University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in pathogenic bacteria in the oropharynx and lower airways	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	During hospitalization, up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
White blood cells	WBC taken pre-op and days 1,2,3 post-op	During hospitalization, up to 4 weeks
CRP	CRP taken pre-op and days 1,2,3 post-op	During hospitalization, up to 4 weeks
Pneumonia	X-ray verified infiltrations in combination with expectorates	Up till 7 days postoperatively
Length of hospital stay	Comparison of length of stay between the intervention group and the control group	time to discharged from hospital or patients death

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University
• Investigators: Principal Investigator: Bengt klarin, MD PhD, Lund University

Publications and helpful links

General Publications

• Stjernquist-Desatnik A, Warfving H, Johansson ML. Persistence of Lactobacillus plantarum DSM 9843 on human tonsillar surface after oral administration in fermented oatmeal gruel. A pilot study. Acta Otolaryngol Suppl. 2000;543:215-9. doi: 10.1080/000164800454422.
• Klarin B, Molin G, Jeppsson B, Larsson A. Use of the probiotic Lactobacillus plantarum 299 to reduce pathogenic bacteria in the oropharynx of intubated patients: a randomised controlled open pilot study. Crit Care. 2008;12(6):R136. doi: 10.1186/cc7109. Epub 2008 Nov 6.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: January 26, 2012
• First Submitted That Met QC Criteria: January 28, 2012
• First Posted (ESTIMATE): January 31, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Probiotics; Anaesthesia; Intubation; Pathogenic bacteria
• Other Study ID Numbers: ProAnest

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results are intended to be published in a scientific journal