Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

Oropharyngeal Microbiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521650
• Other study ID #: ProAnest
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: July 2020

Study information

• Verified date: March 2021
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Microbiology

Intervention

Dietary Supplement:
• Probiotics
Patients will gurgle and swallow a mixture of probiotic bacteria

Locations

Country	Name	City	State
Sweden	Lund University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	White blood cells	WBC taken pre-op and days 1,2,3 post-op	During hospitalization, up to 4 weeks
Secondary	CRP	CRP taken pre-op and days 1,2,3 post-op	During hospitalization, up to 4 weeks
Secondary	Pneumonia	X-ray verified infiltrations in combination with expectorates	Up till 7 days postoperatively
Secondary	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