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Completed

NCT Number: NCT01730066

Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University Hospital

Lund, SE 22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L. plantarum 299 and L. plantarum 299v (+maltodextrin)

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. White Blood Cell count

    Time frame: During hospital stay, expected mean LOS 12 days

    WBC taken pre-op and then on predefined days postoperatively

  2. C Reactive Protein

    Time frame: Throughout the hospital stay, expected mean LOS 12 days

    CRP taken pre-op and then on predefined days postoperatively

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2020
First posted
Nov 21, 2012
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.