Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

NCT ID: NCT01521650

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2020-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Oropharyngeal Microbiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Probiotics

Patients will gurgle and swallow a mixture of probiotic bacteria

Group Type EXPERIMENTAL

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Patients will gurgle and swallow a mixture of probiotic bacteria

Control

No intervention. What has been the standard procedure so far

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Probiotics

Patients will gurgle and swallow a mixture of probiotic bacteria

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Lactobacillus plantarum 299 Lactobacillus plantarum 299v

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Bengt Klarin

MD Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bengt klarin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Lund University Hospital

Lund, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 10909023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18990201 (View on PubMed)

Other Identifiers

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ProAnest

Identifier Type: -

Identifier Source: org_study_id

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