Lund University Hospital
Lund, SE-22185, Sweden
Completed
NCT Number: NCT01521650
Probiotics Against Pathogenic Bacteria 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
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Probiotics
Dietary SupplementPatients will gurgle and swallow a mixture of probiotic bacteria
Other names: Lactobacillus plantarum 299, Lactobacillus plantarum 299v
Primary outcomes
-
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 outcomes
-
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
Sponsors and collaborators
Lead sponsor
Region Skane
Other
Collaborators
- Lund University
Registry information
Official study title
Probiotics for Reduction of Colonisation With Pathogenic Bacteria in the Oropharynx in Connection With Anaesthesia
Important dates
- Study start
- 2012
- Primary completion
- 2019
- Study completion
- 2020
- First posted
- Jan 31, 2012
- Registry last updated
- Mar 10, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.