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Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01521650
Enrollment
42
Registered
2012-01-31
Start date
2012-01-31
Completion date
2020-07-31
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Microbiology

Keywords

Probiotics, Anaesthesia, Intubation, Pathogenic bacteria

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

Interventions

DIETARY_SUPPLEMENTProbiotics

Patients will gurgle and swallow a mixture of probiotic bacteria

Sponsors

Lund University
CollaboratorOTHER
Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Differences in pathogenic bacteria in the oropharynx and lower airwaysDuring hospitalization, up to 4 weeksEmerging 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

MeasureTime frameDescription
White blood cellsDuring hospitalization, up to 4 weeksWBC taken pre-op and days 1,2,3 post-op
CRPDuring hospitalization, up to 4 weeksCRP taken pre-op and days 1,2,3 post-op
PneumoniaUp till 7 days postoperativelyX-ray verified infiltrations in combination with expectorates
Length of hospital staytime to discharged from hospital or patients deathComparison of length of stay between the intervention group and the control group

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026