Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

Study Overview
=================
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. 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

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

Conditions
-----------------
Oropharyngeal Microbiology

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Patients will gurgle and swallow a mixture of probiotic bacteria | Dietary Supplement: Probiotics<br>* Patients will gurgle and swallow a mixture of probiotic bacteria<br>* Other names: Lactobacillus plantarum 299v;|
| No Intervention: Control<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, Anaesthesia, Intubation, Pathogenic bacteria