Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

NCT01521650 | Completed

• 1 other identifier: ProAnest
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Oropharyngeal Microbiology

Keywords

Probiotics; Anaesthesia; Intubation; Pathogenic bacteria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• White blood cells

  During hospitalization, up to 4 weeks

• CRP

  During hospitalization, up to 4 weeks

• Pneumonia

  Up till 7 days postoperatively

• Length of hospital stay

  time to discharged from hospital or patients death

Study Arms (2)

Probiotics

EXPERIMENTAL

Patients will gurgle and swallow a mixture of probiotic bacteria

Dietary Supplement: Probiotics

Control

NO INTERVENTION

No intervention. What has been the standard procedure so far

Interventions

Probiotics DIETARY_SUPPLEMENT

Patients will gurgle and swallow a mixture of probiotic bacteria

Also known as: Lactobacillus plantarum 299, Lactobacillus plantarum 299v

Probiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• Planned interventions
• Anaesthesia \> 4 hours and requiring intubation

You may not qualify if:

• Ulcers in the mouth, oropharynx, oesophagus and stomach
• Current infections in the airways
• Known immuno deficiences
• Emergency cases

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Lund University Hospital

Lund, SE-22185, Sweden

Location

Related Publications (2)

• 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.

  PMID: 10909023 BACKGROUND

• 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.

  PMID: 18990201 BACKGROUND

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bengt klarin, MD PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Consultant

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 31, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)