Clinical trial NCT01730066: Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery
Official title: Probiotics for Reduction of Pathogenic Bacteria in Connection With Advanced Surgery in the Mouth, the Oropharynx, and on the Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced ENT Surgery
Microbiological Flora in the Oropharynx and Lower Airways
Keywords: Probiotics
Pathogenic enteric bacteria
Oropharyngeal flora
CRP
WBC
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2012-11-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Surgery in the mouth and oropharynx is performed in an area colonised by bacteria non-pathogenic and pathogenic.

Antibiotics are used regularly resulting in disturbances in the intestinal microbiological flora and consequently diarrhoea that can be troublesome. The use of antibiotics throughout the hospital stay for these difficult cases represent a risk of development of resistant strains.

Most of the patients have cancer diagnoses and have radiation therapy before surgery. This increases the risk of the patients having pathogenic bacteria normally present in the lower GI-tract.

The investigators have shown for ICU patients that treatment with probiotics reduces the number of emerging enteral bacteria in the oropharynx and now the investigators will perform an adjusted procedure for patients planned for large ear, nose, and throat (ENT) surgery.

Patients will preoperatively gurgle a suspension of probiotics and then swallow the preparation.

Postoperatively the probiotics is given enterally and a eventually by mouth again.

Cultures will be taken from the oropharynx and tracheal secretions and the results will be compared

Detailed description: 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 hospital.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in pathogenic bacteria in the oropharynx
timeFrame: During hospitalization, anticipated mean time 12 days
Secondary outcomes:
measure: White Blood Cell count
timeFrame: During hospital stay, expected mean LOS 12 days
measure: C Reactive Protein
timeFrame: Throughout the hospital stay, expected mean LOS 12 days
measure: Length of Hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2-3 weeks
measure: Survival
timeFrame: Six months
measure: Diarrhoea and obstipation
timeFrame: Throughout the hospital stay, expected mean LOS 12 days
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
affiliation: Lund University Hospital
name: Bengt Klarin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1080/000164800454422.
citation: 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.