Pathogenic Bacteria in the OropharynxNCT01105819
Chlorhexidine vs Lactobacillus Plantarum for Oral Care in Intubated ICU Patients
A study testing Lactobacillus plantarum 299 for oral care and Chlorhexidine for standard oral care in people with Pathogenic Bacteria in the Oropharynx and Ventilator-associated Pneumonia, run by Region Skane at 3 sites in Sweden.
Trial summary
Critically ill patients often need ventilatory support through a plastic tube connected to a ventilator. Those patients have a altered microbiological flora in the mouth, oropharynx as well as throughout the intestine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathogenic Bacteria in the Oropharynx, Ventilator-associated Pneumonia
- What is being tested?
- Lactobacillus plantarum 299 for oral care and Chlorhexidine for standard oral care
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesSweden
- Study dates
- Apr 2010to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Critically ill patients anticipated to require mechanical ventilation for at least 24 hours
Who cannot join
- Pneumonia as admission diagnosis,
- Fractures on the facial skeleton or the skull base;
- Known ulcers in the oral cavity, the oropharynx, or the esophagus
- Known immune difficency
- Carrier of HIV or Hepatitis
- Patient being moribund
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Intensive Care Unit, Halmstad Central Hospital
Halmstad, SE 301 85
Intensive Care Unit, Kristianstad Central hospital
Kristianstad, SE 291 85
Intensive Care Unit, Lund University Hospital
Lund, SE 221 85
About this study
Official title: A Study Comparing a Suspension of Lactobacillus Plantarum 299 With Chlorhexidine for Oral Care in Intubated Mechanically Ventilated Patients in Intensive Care
Critically ill patients often need ventilatory support through a plastic tube connected to a ventilator. Those patients have a altered microbiological flora in the mouth, oropharynx as well as throughout the intestine. Bacteria that can cause illness are often found in the oropharynx in such patients and measures are taken in order to reduce the risk of secondary infections by those bacteria. In all intensive care patients oral care is provided by the nursing staff aiming at a reduction of the pathogenic species. This is done by a variety measures.
Chlorhexidine (CHX) is an antisepticum with a capability to reduce bacterial counts in the mouth and oropharynx and has been shown to be of value also for intubated patients. It is used frequently throughout the world.
Read more
Ventilator-associated pneumonia (VAP) is a costly rather frequent complication to intensive care and mechanical ventilation and is usually caused by aspiration of infected secretions from the oropharynx. CHX has in some studies been shown to reduce the frequency of VAP.
The probiotic bacterium Lactobacillus plantarum 299 has the ability to adhere to the mucosa throughout the gastro-intestinal tract including the mouth and in our pilot study we found that L plantarum had better ability to reduce colonisation with enteric bacteria in the oropharynx than CHX had. Figures not statistical significant so this present study is aiming to get a larger amount of data.
The procedure was found to be safe Hypothesis: Lactobacillus plantarum is better than CHX for the reduction of pathogenic bacteria in the oropharynx in intubated mechanically ventilated patients and consequently has a better potential to reduce the frequency of VAP
Read the detailed description
This study is an expansion of a pilot study performed at the ICU Lund University Hospital, Sweden where 50 patients were included (ISRCTN00472141).
Results have been published in Critical Care 2008, 12:R136 The protocol is the same and in this second phase we intend to include 100 patients and results will be summed up.
Three centres are engaged. The results from the pilot study is encouraging and we are aiming at getting statistical significance in the differences in pathogenic findings in the cultures from oropharynx and also better a better basis for the calculation of the number of patients needed to get sufficient power to study difference in VAP frequency.
- Being tested
- Lactobacillus plantarum 299 for oral care, Chlorhexidine for standard oral care
- Keywords
- Probiotics, Lactobacillus plantarum 299, Ventilator-associated pneumonia VAP, Chlorhexidine, Tracheal secretions, Oropharyngeal secretions
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum 299 for oral careProcedure or surgery
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
Chlorhexidine for standard oral careProcedure or surgery
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 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
| Study group | Role | What they receive |
|---|---|---|
| Standard oral care with chlorhexidine | Other | The control group will receive a standard oral care. 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 Receives: Procedure: Chlorhexidine for standard oral care |
| Lactobacillus plantarum 299 | Active comparator | 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 Receives: Procedure: Lactobacillus plantarum 299 for oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the number and frequency of cultures with pathogenic bacteria and fungi from the oropharynx and tracheal secretions and the spectra of these microbiological species
Measured: During study time in connection with the care in the ICU until invasive mechanical ventilation is terminated
Recovery of Lactobacillus plantarum 299 in tracheal secretions in the active treatment group as an indicator of aspiration
Measured: During study time in connection with the care in the ICU until invasive mechanical ventilation is terminated
Secondary outcomes (7)
SOFA score and Influence on lung function measured as Lung Injury Severity Score
Measured: From admission to the ICU til discharge from the ICU
Difference in emerge of Ventilator Associated Pneumonia
Measured: During ICU stay
Validation of micobiological findings compared to the use of antibiotics
Measured: ICU stay + 48 hours
C-reactive protein and white blood cell counts
Measured: From admission to the ICU til discharge from the ICU
Evaluation of microbiological cultures taken on clinical grounds
We want to examine the possible influence of the added probioticum on the frequence of positive cultures from other sites than those taken per protocol.
Samples taken during ICU-stay and 48 hours after discharge from the ICU will be examened The type of species in positive cultures are also of interest. Blood cultures may act as indicator of vascular spread of the studied bacterium.
According to the protocol samples for blood cultures are not taken
Measured: ICU-stay + 48 hours
28 day mortality
Measured: 28 days after ICU admission
6 months mortality
Measured: 6 months after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pathogenic Bacteria in the OropharynxStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- County Council of Halland, Sweden, Probi AB
- Responsible party
- Principal investigator, Bengt Klarin, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105819
- Sponsor's protocol ID
- PROHYG 1B
- Status last verified
- May 2018
- First submitted
- 9 Apr 2010
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Results are under review and are planned for publishing in a scientific journal
Publications
Klarin B, Molin G, Jeppsson B, Larsson A. Use of the probiotic Lactobacillus plantarum 299 to reduce pathogenic bacteria in the oropharynx of intubated patients: a randomised controlled open pilot study. Crit Care. 2008;12(6):R136. doi: 10.1186/cc7109. Epub 2008 Nov 6.
PubMed 18990201Klarin B, Adolfsson A, Torstensson A, Larsson A. Can probiotics be an alternative to chlorhexidine for oral care in the mechanically ventilated patient? A multicentre, prospective, randomised controlled open trial. Crit Care. 2018 Oct 28;22(1):272. doi: 10.1186/s13054-018-2209-4.
PubMed 30368249
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing a Suspension of Lactobacillus Plantarum 299 With Chlorhexidine for Oral Care in Intubated Mechanically Ventilated Patients in Intensive Care
- ClinicalTrials.gov ID
- NCT01105819
- Acronym / sponsor ID
- PROHYG 1B
- Keywords
- Probiotics, Lactobacillus plantarum 299, Ventilator-associated pneumonia VAP, Chlorhexidine, Tracheal secretions, Oropharyngeal secretions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- County Council of Halland, Sweden, Probi AB
- Study start
- Apr 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 19 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Critically ill patients often need ventilatory support through a plastic tube connected to a ventilator. Those patients have a altered microbiological flora in the mouth, oropharynx as well as throughout the intestine. Bacteria that can cause illness are often found in the oropharynx in such patients and measures are taken in order to reduce the risk of secondary infections by those bacteria. In all intensive care patients oral care is provided by the nursing staff aiming at a reduction of the pathogenic species. This is done by a variety measures.
Chlorhexidine (CHX) is an antisepticum with a capability to reduce bacterial counts in the mouth and oropharynx and has been shown to be of value also for intubated patients. It is used frequently throughout the world.
Ventilator-associated pneumonia (VAP) is a costly rather frequent complication to intensive care and mechanical ventilation and is usually caused by aspiration of infected secretions from the oropharynx. CHX has in some studies been shown to reduce the frequency of VAP.
The probiotic bacterium Lactobacillus plantarum 299 has the ability to adhere to the mucosa throughout the gastro-intestinal tract including the mouth and in our pilot study we found that L plantarum had better ability to reduce colonisation with enteric bacteria in the oropharynx than CHX had. Figures not statistical significant so this present study is aiming to get a larger amount of data.
The procedure was found to be safe Hypothesis: Lactobacillus plantarum is better than CHX for the reduction of pathogenic bacteria in the oropharynx in intubated mechanically ventilated patients and consequently has a better potential to reduce the frequency of VAP
Detailed description
This study is an expansion of a pilot study performed at the ICU Lund University Hospital, Sweden where 50 patients were included (ISRCTN00472141).
Results have been published in Critical Care 2008, 12:R136 The protocol is the same and in this second phase we intend to include 100 patients and results will be summed up.
Three centres are engaged. The results from the pilot study is encouraging and we are aiming at getting statistical significance in the differences in pathogenic findings in the cultures from oropharynx and also better a better basis for the calculation of the number of patients needed to get sufficient power to study difference in VAP frequency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard oral care with chlorhexidine | Other | Procedure: Chlorhexidine for standard oral careThe control group will receive a standard oral care. 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 |
| Lactobacillus plantarum 299 | Active comparator | Procedure: Lactobacillus plantarum 299 for oral careThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Critically ill patients anticipated to require mechanical ventilation for at least 24 hours
Key exclusion criteria (6 listed)
- Pneumonia as admission diagnosis,
- Fractures on the facial skeleton or the skull base;
- Known ulcers in the oral cavity, the oropharynx, or the esophagus
- Known immune difficency
- Carrier of HIV or Hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus plantarum 299 for oral careThe 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 | Procedure or surgery | Lactobacillus plantarum 299 |
| Chlorhexidine for standard oral careA 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 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 | Procedure or surgery | Standard oral care with chlorhexidine |
Primary outcome
To compare the number and frequency of cultures with pathogenic bacteria and fungi from the oropharynx and tracheal secretions and the spectra of these microbiological species
Time frame: During study time in connection with the care in the ICU until invasive mechanical ventilation is terminated
Recovery of Lactobacillus plantarum 299 in tracheal secretions in the active treatment group as an indicator of aspiration
Time frame: During study time in connection with the care in the ICU until invasive mechanical ventilation is terminated
7 secondary outcomes
SOFA score and Influence on lung function measured as Lung Injury Severity Score
Time frame: From admission to the ICU til discharge from the ICU
Difference in emerge of Ventilator Associated Pneumonia
Time frame: During ICU stay
Validation of micobiological findings compared to the use of antibiotics
Time frame: ICU stay + 48 hours
C-reactive protein and white blood cell counts
Time frame: From admission to the ICU til discharge from the ICU
Evaluation of microbiological cultures taken on clinical grounds
Time frame: ICU-stay + 48 hours
28 day mortality
Time frame: 28 days after ICU admission
6 months mortality
Time frame: 6 months after ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Results publication: PubMed 18990201Klarin B, Molin G, Jeppsson B, Larsson A. Use of the probiotic Lactobacillus plantarum 299 to reduce pathogenic bacteria in the oropharynx of intubated patients: a randomised controlled open pilot study. Crit Care. 2008;12(6):R136. doi: 10.1186/cc7109. Epub 2008 Nov 6.
- Derived from this study: PubMed 30368249Klarin B, Adolfsson A, Torstensson A, Larsson A. Can probiotics be an alternative to chlorhexidine for oral care in the mechanically ventilated patient? A multicentre, prospective, randomised controlled open trial. Crit Care. 2018 Oct 28;22(1):272. doi: 10.1186/s13054-018-2209-4.
- Individual participant dataSharing planned: Yes. Results are under review and are planned for publishing in a scientific journal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum 299 for oral care and Chlorhexidine for standard oral care in people with Pathogenic Bacteria in the Oropharynx and Ventilator-associated Pneumonia, run by Region Skane at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the number and frequency of cultures with pathogenic bacteria and fungi from the oropharynx and tracheal secretions and the spectra of these microbiological species (time frame: During study time in connection with the care in the ICU until invasive mechanical ventilation is terminated). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01105819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.