Condition category
Oral Health
Date applied
22/11/2007
Date assigned
02/01/2008
Last edited
02/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.probi.com/

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

Publication citations

Additional files

Editorial Notes