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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN00472141

Enrollment

Registered

2008-01-02

Start date

2004-01-10

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth of pathogenic bacteria in the oral cavity Oral Health Growth of pathogenic bacteria in the oral cavity

Interventions

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 (genera

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18 years or older 2. Critically ill patients anticipated to require mechanical ventilation for at least 24 hours

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026