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 number | NCT01105819 |
| Secondary identifying numbers | PROHYG |
- 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
Scientific
Department of Anaesthesiology and Intensive Care
Lund University Hospital
Lund
SE 221 85
Sweden
| Phone | +46 (0)46 171949 |
|---|---|
| Bengt.Klarin@med.lu.se |
Study information
| Study design | Pilot, prospective, open, randomised controlled study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lactobacillus plantarum and chlorhexidine |
| Primary outcome measure | 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 study start date | 10/01/2004 |
| Completion date | 15/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
SE 221 85
Sweden
Sponsor information
Probi AB (Sweden)
Industry
Industry
Ideon Gamma 1
Sölvegatan 41
Lund
SE 22370
Sweden
| Phone | +46 (0)46 286 89 20 |
|---|---|
| probi@probi.se | |
| Website | http://www.probi.com/ |
"ROR" |
https://ror.org/03yf63872 |
Funders
Funder type
Industry
Probi AB (Sweden)
No information available
Region Skane (Regional public body responsible for health, medical and dental services)(Sweden)
No information available
The Scandinavian Society for Antimicrobial Chemotherapy Foundation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
