Contact information
Type
Scientific
Primary contact
Dr Bengt Klarin
ORCID ID
Contact details
Department of Anaesthesiology and Intensive Care
Lund University Hospital
Lund
SE 221 85
Sweden
+46 (0)46 171949
Bengt.Klarin@med.lu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PROHYG
Study information
Scientific title
Acronym
Study hypothesis
The probiotic bacterium Lactobacillus plantarum 299 reduces growth of pathogenic bacteria in the oral cavity in intubated patients to the same extent as chlorhexidin but is a better ecologic alternative.
Ethics approval
Final ethical approval was obtained from the Human Ethics Committee at the Lund University on the 29th September 2003 (ref: LU 346-03)
Study design
Pilot, prospective, open, randomised controlled study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Growth of pathogenic bacteria in the oral cavity
Intervention
Ramdomisation is carried out in groups of 10 participants. 20 participants are allocated to each of the two groups.
A The control group will receive the standard oral care of the department (general ICU, Lund University Hospital).
This includes suction of secretions, brushing of teeth cleansing of the oral cavity with swabs soaked with a chlorhexidine solution. This procedure is performed twice a day. In between, suction whenever needed and cleansing with swabs soaked with carbonated bottled water is performed
B The study group will be attended in the same manor but the swabs used for cleansing are soaked with carbonated water directly from freshly opened bottles. As the final part of the procedure oral mucosal surfaces are pencilled with a suspension of the probiotic bacterium Lactobacillus plantarum 299
Cultures from the oropharynx and tracheal secretions are taken at inclusion (day 1) and then on days 2,3,5,7,10,14 and 21 or before extubation if this occurs on a non-culture day
Intervention type
Drug
Phase
Not Specified
Drug names
Lactobacillus plantarum and chlorhexidin
Primary outcome measures
Cultures from the oropharynx and tracheal secretions are taken at inclusion (day 1) and then on days 2, 3, 5, 7, 10, 14 and 21 or before extubation if this occurs on a non-culture day (The primary outcomes are validated for the part of the ICU stay during which the patient is intubated). The results of the cultures are used to assess the following:
1. To compare the number of cultures with pathogenic bacteria and fungi from oropharynx and tracheal secretions and the spectra of these microbiologic species
2. Recovery of Lactobacillus plantarum 299 in the treatment group as an indicator of aspiration
Secondary outcome measures
The following will be assessed during the ICU stay during which the patient is intubated:
1. Sequential Organ Failure Assessment (SOFA) score and Lung Injury Severity Score (LISS) will be measured daily during the ICU stay
2. Incidence of ventilator associated pneumonia during the ICU stay
3. Validation of microbiological findings compared to the use of antibiotics, monitored during the ICU stay
4. Infectious parameters (C-Reactive Protein [CRP] and White Blood Cell counts [WBC]), monitored daily during the ICU stay
For the whole ICU period:
5. ICU mortality
For the post-extubation period:
6. In-hospital mortality
Follow-up for survival will be carried out for 6 months from admission to the ICU.
Overall trial start date
10/01/2004
Overall trial end date
15/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. 18 years or older
2. Critically ill patients anticipated to require mechanical ventilation for at least 24 hours
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Diagnosed with pneumonia at admission
2. Fractures on the facial skeleton or the skull base
3. Known ulcers in the oral cavity
4. Carrier of HIV or Hepatitis
5. Moribund
Recruitment start date
10/01/2004
Recruitment end date
15/12/2007
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Anaesthesiology and Intensive Care
Lund
SE 221 85
Sweden
Sponsor information
Organisation
Probi AB (Sweden)
Sponsor details
Ideon Gamma 1
Sölvegatan 41
Lund
SE 22370
Sweden
+46 (0)46 286 89 20
probi@probi.se
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Probi AB (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Region Skane (Regional public body responsible for health, medical and dental services)(Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Scandinavian Society for Antimicrobial Chemotherapy Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary