Clinical trial NCT01105819: Chlorhexidine vs Lactobacillus Plantarum for Oral Care in Intubated ICU Patients
Official title: A Study Comparing a Suspension of Lactobacillus Plantarum 299 With Chlorhexidine for Oral Care in Intubated Mechanically Ventilated Patients in Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathogenic Bacteria in the Oropharynx
Ventilator-associated Pneumonia
Keywords: Probiotics
Lactobacillus plantarum 299
Ventilator-associated pneumonia VAP
Chlorhexidine
Tracheal secretions
Oropharyngeal secretions
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: County Council of Halland, Sweden
name: Probi AB
First posted: 2010-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Critically ill patients often need ventilatory support through a plastic tube connected to a ventilator. Those patients have a altered microbiological flora in the mouth, oropharynx as well as throughout the intestine. Bacteria that can cause illness are often found in the oropharynx in such patients and measures are taken in order to reduce the risk of secondary infections by those bacteria. In all intensive care patients oral care is provided by the nursing staff aiming at a reduction of the pathogenic species. This is done by a variety measures.

Chlorhexidine (CHX) is an antisepticum with a capability to reduce bacterial counts in the mouth and oropharynx and has been shown to be of value also for intubated patients. It is used frequently throughout the world.

Ventilator-associated pneumonia (VAP) is a costly rather frequent complication to intensive care and mechanical ventilation and is usually caused by aspiration of infected secretions from the oropharynx. CHX has in some studies been shown to reduce the frequency of VAP.

The probiotic bacterium Lactobacillus plantarum 299 has the ability to adhere to the mucosa throughout the gastro-intestinal tract including the mouth and in our pilot study we found that L plantarum had better ability to reduce colonisation with enteric bacteria in the oropharynx than CHX had. Figures not statistical significant so this present study is aiming to get a larger amount of data.

The procedure was found to be safe Hypothesis: Lactobacillus plantarum is better than CHX for the reduction of pathogenic bacteria in the oropharynx in intubated mechanically ventilated patients and consequently has a better potential to reduce the frequency of VAP

Detailed description: This study is an expansion of a pilot study performed at the ICU Lund University Hospital, Sweden where 50 patients were included (ISRCTN00472141).

Results have been published in Critical Care 2008, 12:R136 The protocol is the same and in this second phase we intend to include 100 patients and results will be summed up.

Three centres are engaged. The results from the pilot study is encouraging and we are aiming at getting statistical significance in the differences in pathogenic findings in the cultures from oropharynx and also better a better basis for the calculation of the number of patients needed to get sufficient power to study difference in VAP frequency.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Critically ill patients anticipated to require mechanical ventilation for at least 24 hours

Exclusion Criteria:

* Pneumonia as admission diagnosis,
* Fractures on the facial skeleton or the skull base;
* Known ulcers in the oral cavity, the oropharynx, or the esophagus
* Known immune difficency
* Carrier of HIV or Hepatitis
* Patient being moribund

Primary outcomes:
measure: To compare the number and frequency of cultures with pathogenic bacteria and fungi from the oropharynx and tracheal secretions and the spectra of these microbiological species
timeFrame: During study time in connection with the care in the ICU until invasive mechanical ventilation is terminated
measure: Recovery of Lactobacillus plantarum 299 in tracheal secretions in the active treatment group as an indicator of aspiration
timeFrame: During study time in connection with the care in the ICU until invasive mechanical ventilation is terminated
Secondary outcomes:
measure: SOFA score and Influence on lung function measured as Lung Injury Severity Score
timeFrame: From admission to the ICU til discharge from the ICU
measure: Difference in emerge of Ventilator Associated Pneumonia
timeFrame: During ICU stay
measure: Validation of micobiological findings compared to the use of antibiotics
timeFrame: ICU stay + 48 hours
measure: C-reactive protein and white blood cell counts
timeFrame: From admission to the ICU til discharge from the ICU
measure: Evaluation of microbiological cultures taken on clinical grounds
timeFrame: ICU-stay + 48 hours
measure: 28 day mortality
timeFrame: 28 days after ICU admission
measure: 6 months mortality
timeFrame: 6 months after ICU admission
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Intensive Care Unit, Halmstad Central Hospital
city: Kristianstad
country: Sweden
facility: Intensive Care Unit, Kristianstad Central hospital
city: Lund
country: Sweden
facility: Intensive Care Unit, Lund University Hospital
Study officials:
References:
citation: Klarin B, Molin G, Jeppsson B, Larsson A. Use of the probiotic Lactobacillus plantarum 299 to reduce pathogenic bacteria in the oropharynx of intubated patients: a randomised controlled open pilot study. Crit Care. 2008;12(6):R136. doi: 10.1186/cc7109. Epub 2008 Nov 6.
citation: Klarin B, Adolfsson A, Torstensson A, Larsson A. Can probiotics be an alternative to chlorhexidine for oral care in the mechanically ventilated patient? A multicentre, prospective, randomised controlled open trial. Crit Care. 2018 Oct 28;22(1):272. doi: 10.1186/s13054-018-2209-4.