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Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery

NCT01730066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-10-12

No results posted yet for this study

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

Conditions

  • Advanced ENT Surgery
  • Microbiological Flora in the Oropharynx and Lower Airways

Interventions

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

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Region Skane

    lead OTHER

Principal Investigators

  • Bengt Klarin, MD, PhD · Lund University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2019-12-31
Completion
2020-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01730066 on ClinicalTrials.gov