A study comparing a suspension of Lactobacillus plantarum 299 with chlorhexidine for oral care in intubated mechanically ventilated patients in intensive care

ISRCTN	ISRCTN00472141
DOI	https://doi.org/10.1186/ISRCTN00472141
ClinicalTrials.gov (NCT)	NCT01105819
Protocol serial number	PROHYG
Sponsor	Probi AB (Sweden)
Funders	Probi AB (Sweden), Region Skane (Regional public body responsible for health, medical and dental services)(Sweden), The Scandinavian Society for Antimicrobial Chemotherapy Foundation

Submission date: 22/11/2007
Registration date: 02/01/2008
Last edited: 31/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Bengt Klarin
Scientific

Department of Anaesthesiology and Intensive Care
Lund University Hospital
Lund
SE 221 85
Sweden

Phone	+46 (0)46 171949
Email	Bengt.Klarin@med.lu.se

Study information

Primary study design	Interventional
Study design	Pilot, prospective, open, randomised controlled study.
Secondary study design	Randomised controlled trial
Scientific title	A study comparing a suspension of Lactobacillus plantarum 299 with chlorhexidine for oral care in intubated mechanically ventilated patients in intensive care
Study objectives	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(s)	Final ethical approval was obtained from the Human Ethics Committee at the Lund University on the 29th September 2003 (ref: LU 346-03)
Health condition(s) or problem(s) studied	Growth of pathogenic bacteria in the oral cavity
Intervention	Randomisation 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 / device / biological / vaccine name(s)	Lactobacillus plantarum and chlorhexidine
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	15/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Total final enrolment	50
Key inclusion criteria	1. 18 years or older 2. Critically ill patients anticipated to require mechanical ventilation for at least 24 hours
Key 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
Date of first enrolment	10/01/2004
Date of final enrolment	15/12/2007

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Anaesthesiology and Intensive Care

Lund
SE 221 85
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	expanded study results	28/10/2018	31/12/2020	Yes	No
Results article	pilot study results	01/12/2008	31/12/2020	Yes	No

Editorial Notes

31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NCT code has been added.