Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lactobacillus Plantarum 299v in Colon Surgery

NCT00695461

Bacterial Translocation Inflammation Cell Proliferation

COMPLETED NA

Changes of Oropharyngeal Flora

NCT02303301

Pharyngeal Bacterial Colonization Pneumonia

COMPLETED NA

Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

NCT01521650

Oropharyngeal Microbiology

COMPLETED NA

Interventional Study to Evaluate the Effect of the Oral Administration of L.Plantarum on Vaginal Microbiota

NCT04461782

Vaginal Infection

COMPLETED NA

Use of Probiotics in Oral Health of Patients With Dental Implants

NCT01974596

Mucositis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced ENT Surgery Microbiological Flora in the Oropharynx and Lower Airways

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotics

Patients will gurgle and swallow a mixture of probiotic bacteria preoperatively and given the same study product enterally postoperatively

Group Type EXPERIMENTAL

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

Intervention Type 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

Control

No intervention.What has been the standard procedure so far

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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