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Probiotics for Reduction of Pathogenic Bacteria in Connection With Advanced Surgery in the Mouth, the Oropharynx, and on the Neck

18 Years
Open (Enrolling)
Advanced ENT Surgery, Microbiological Flora in the Oropharynx and Lower Airways

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Trial Information

Probiotics for Reduction of Pathogenic Bacteria in Connection With Advanced Surgery in the Mouth, the Oropharynx, and on the Neck

Longer surgical procedures require intubation and there is a potential risk of contaminating
the lower airways with pathogenic bacteria from the mouth and oropharynx.

Surgery including the mouth and the oropharynx is performed in an area that is colonised by
hundreds of different bacterial species. In the healthy person there is a balance between
the different microbes and possible pathogens are kept under control.

Patients that are subject to surgery in the mouth, oropharynx or neck area, most often have
cancer diagnoses. Preoperative treatment (mostly radiation) is done in most cases resulting
in a changed spectrum of bacteria in the mouth and oropharynx. Due to lowered appetite
increased difficulties to eat, in combination with cancer diagnosis, there is also a change
in cranial direction of the microbiological gut flora resulting in the presence of pathogens
such as Gram-negative bacteria. Those species may result in troublesome infections in the
postoperative period.

With healthy people pathogenic bacteria originating from the gastro/intestinal canal are
seldom found in the oropharynx, but those do occur among many patients.

Antibiotics are used prophylactic and for more extensive surgery, as micro vascular
procedures with free transplants of tissues, antibiotics are kept throughout the length of
stay (LOS) in hospital. This results in an increased risk for the development of resistant
bacteria and does result in changes in the GI flora in those patients. Diarrhoea occurs
frequently and are troublesome for the patients For ICU patients we have seen a reduction of
emerging enteric bacteria in patients given oral care with probiotics and this study will
explore the possibility of the same kind of positive effects in patients due for extensive
surgery performed during several hours.

Many of the patients will have a tracheostomy performed as part of the surgical procedure.

Patients will be randomised (1:1) to either no prophylaxis (standard procedure today) or to
preparation with a probiotic suspension fro the day before surgery until discharge from

Preoperatively the patients will gurgle a suspension of probiotics and then swallow the

Postoperatively the probiotics is given enterally and a eventually when the responsible
surgeon find it suitable by mouth again.

Cultures at inclusion, after intubation, and then on predefined days postoperatively to
compare bacterial flora in the oropharynx and in tracheal secretions.

Infectious parameters will be followed.

Inclusion Criteria:

- Elective advanced and extensive ENT surgery

- Adult patients (≥ 18 years)

- Surgery requires general anesthesia and endotracheal intubation

- Length of anesthesia ≥ 1,5 hours

- Signed informed consent

Exclusion Criteria:

- Ongoing treatment requiring infection in the lower respiratory tract

- Chronic lung disease requiring oxygen treatment

- Known immune deficiency

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Differences in pathogenic bacteria in the oropharynx

Outcome Description:

Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in connection to a surgical intervention and postoperatively

Outcome Time Frame:

During hospitalization, anticipated mean time 12 days

Safety Issue:


Principal Investigator

Bengt Klarin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lund University Hospital


Sweden: Regional Ethical Review Board

Study ID:




Start Date:

October 2012

Completion Date:

April 2015

Related Keywords:

  • Advanced ENT Surgery
  • Microbiological Flora in the Oropharynx and Lower Airways
  • Probiotics
  • Pathogenic enteric bacteria
  • Oropharyngeal flora
  • CRP
  • WBC