Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    10909023 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01730066
Recruitment Status : Recruiting
First Posted : November 21, 2012
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane

Tracking Information
First Submitted Date  ICMJE November 8, 2012
First Posted Date  ICMJE November 21, 2012
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE October 2012
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
Differences in pathogenic bacteria in the oropharynx [ Time Frame: During hospitalization, anticipated mean time 12 days ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01730066 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
  • White Blood Cell count [ Time Frame: During hospital stay, expected mean LOS 12 days ]
    WBC taken pre-op and then on predefined days postoperatively
  • C Reactive Protein [ Time Frame: Throughout the hospital stay, expected mean LOS 12 days ]
    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 ]
    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 ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery
Official Title  ICMJE Probiotics for Reduction of Pathogenic Bacteria in Connection With Advanced Surgery in the Mouth, the Oropharynx, and on the Neck
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Advanced ENT Surgery
  • Microbiological Flora in the Oropharynx and Lower Airways
Intervention  ICMJE 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

Study Arms  ICMJE
  • Experimental: Probiotics
    Patients will gurgle and swallow a mixture of probiotic bacteria preoperatively and given the same study product enterally postoperatively
    Intervention: Dietary Supplement: L. plantarum 299 and L. plantarum 299v (+maltodextrin)
  • No Intervention: Control
    No intervention.What has been the standard procedure so far
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2012)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bengt Klarin, MD, PhD +4646171941 Bengt.Klarin@med.lu.se
Contact: Anna Tranberg Lindqvist, MD +4646172233 Anna.TranbergLindqvist@skane.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01730066
Other Study ID Numbers  ICMJE ProOncENT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Results will be published in a scientific journal
Responsible Party Region Skane
Study Sponsor  ICMJE Region Skane
Collaborators  ICMJE Lund University
Investigators  ICMJE
Principal Investigator: Bengt Klarin, MD, PhD Lund University Hospital
PRS Account Region Skane
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP