Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Region Skane
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01730066
First received: November 8, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Advanced ENT Surgery
Microbiological Flora in the Oropharynx and Lower Airways
Dietary Supplement: L. plantarum 299 and L. plantarum 299v (+maltodextrin)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Probiotics for Reduction of Pathogenic Bacteria in Connection With Advanced Surgery in the Mouth, the Oropharynx, and on the Neck

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Differences in pathogenic bacteria in the oropharynx [ Time Frame: During hospitalization, anticipated mean time 12 days ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • White Blood Cell count [ Time Frame: During hospital stay, expected mean LOS 12 days ] [ Designated as safety issue: No ]
    WBC taken pre-op and then on predefined days postoperatively

  • C Reactive Protein [ Time Frame: Throughout the hospital stay, expected mean LOS 12 days ] [ Designated as safety issue: No ]
    CRP taken pre-op and then on predefined days postoperatively

  • Length of Hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2-3 weeks ] [ Designated as safety issue: No ]
    Length of stay is recorded for the Hospital stay, and for those cases that have an extended post-operative period in the ICU, the length of the ICU stay will be recorded

  • Survival [ Time Frame: Six months ] [ Designated as safety issue: No ]
    For participating patients the status of survival or non survival at days 28 and 180 (six months) will be recorded

  • Diarrhoea and obstipation [ Time Frame: Throughout the hospital stay, expected mean LOS 12 days ] [ Designated as safety issue: No ]

    As ICU patients tend to display diarrhoea as well as obstipation the frequency and consistency of stools will be recorded.

    Probiotics are anticipated to stabilise bowel function



Estimated Enrollment: 102
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics
Patients will gurgle and swallow a mixture of probiotic bacteria preoperatively and given the same study product enterally postoperatively
Dietary Supplement: L. plantarum 299 and L. plantarum 299v (+maltodextrin)

Patients will be given a mixture of maltodextrin ( a starch product often used i alimentary products) and two strains of probiotic bacteria ( L. plantarum 299 and L. plantarum 299v ) dissolved in water. They will gurgle and swallow the suspension from the day before surgery. Postoperatively they will be given the probiotic mixture via a nasogastric tubing twice a day and when the responsible surgeon find it suitable also orally as described above. When they can swallow no study product is given through the nasogastric tube.

Patients randomized 1:1 between groups

No Intervention: Control
No intervention.What has been the standard procedure so far

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730066

Contacts
Contact: Bengt Klarin, MD, PhD +4646171941 Bengt.Klarin@med.lu.se
Contact: Anna Tranberg Lindqvist, MD +4646172233 anna.tranberg@skane.se

Locations
Sweden
Lund University Hospital Recruiting
Lund, Sweden, SE 22185
Contact: Bengt Klarin, MD, PhD    +4646171941    Bengt.Klarin@med.lu.se   
Contact: Anna Tranberg Lindqvis, MD    +4646172233    anna.tranberg@skane.se   
Principal Investigator: Bengt Klarin, MD, PhD         
Sub-Investigator: Anna Tranberg Lindqvist, MD         
Sub-Investigator: Anne Adolfsson, RN         
Sponsors and Collaborators
Region Skane
Lund University
Investigators
Principal Investigator: Bengt Klarin, MD, PhD Lund University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01730066     History of Changes
Other Study ID Numbers: ProOncENT
Study First Received: November 8, 2012
Last Updated: August 5, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Probiotics
Pathogenic enteric bacteria
Oropharyngeal flora
CRP
WBC

ClinicalTrials.gov processed this record on October 20, 2014