Oropharyngeal MicrobiologyNCT01521650
Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia
A study testing Probiotics in people with Oropharyngeal Microbiology, run by Region Skane at 1 site in Sweden.
Trial summary
Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx. Healthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal but those do occur among patients, both in those not so sick… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Microbiology
- What is being tested?
- Probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2012to Jul 2020
- 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
- Adult patients
- Planned interventions
- Anaesthesia > 4 hours and requiring intubation
Who cannot join
- Ulcers in the mouth, oropharynx, oesophagus and stomach
- Current infections in the airways
- Known immuno deficiences
- Emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics for Reduction of Colonisation With Pathogenic Bacteria in the Oropharynx in Connection With Anaesthesia
Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.
Healthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal but those do occur among patients, both in those not so sick and patients with more severe problems.
Read more
For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this is a pilot study to explore the possibility of the same kind of positive effects in patients due for longer (more than 4 hours of anesthesia) procedures.
Randomisation
- No prophylaxis
- Preparation with a probiotic suspension before intubation.
Cultures
- oropharynx
- before treatment
- after intubation
- before extubation
- day 1 postoperatively
- tracheal secretions
- after intubation
- before extubation
- Conditions
- Oropharyngeal Microbiology
- Being tested
- Probiotics
- Keywords
- Probiotics, Anaesthesia, Intubation, Pathogenic bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Also called Lactobacillus plantarum 299, Lactobacillus plantarum 299v
Patients will gurgle and swallow a mixture of probiotic bacteria
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Patients will gurgle and swallow a mixture of probiotic bacteria Receives: Dietary Supplement: Probiotics |
| Control | No intervention | No intervention. What has been the standard procedure so far |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in pathogenic bacteria in the oropharynx and lower airways
Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in conection with anaestesia and a surgical intervention
Measured: During hospitalization, up to 4 weeks
Secondary outcomes (4)
White blood cells
WBC taken pre-op and days 1,2,3 post-op
Measured: During hospitalization, up to 4 weeks
CRP
CRP taken pre-op and days 1,2,3 post-op
Measured: During hospitalization, up to 4 weeks
Pneumonia
X-ray verified infiltrations in combination with expectorates
Measured: Up till 7 days postoperatively
Length of hospital stay
Comparison of length of stay between the intervention group and the control group
Measured: time to discharged from hospital or patients death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2019
- Study completionJul 2020
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 Oropharyngeal MicrobiologyStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Bengt Klarin, Region Skane
- Investigators
- Bengt klarin, MD PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521650
- Sponsor's protocol ID
- ProAnest
- Status last verified
- Mar 2021
- First submitted
- 26 Jan 2012
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Results are intended to be published in a scientific journal
Publications
Stjernquist-Desatnik A, Warfving H, Johansson ML. Persistence of Lactobacillus plantarum DSM 9843 on human tonsillar surface after oral administration in fermented oatmeal gruel. A pilot study. Acta Otolaryngol Suppl. 2000;543:215-9. doi: 10.1080/000164800454422.
PubMed 10909023Klarin 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 18990201
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Reduction of Colonisation With Pathogenic Bacteria in the Oropharynx in Connection With Anaesthesia
- ClinicalTrials.gov ID
- NCT01521650
- Acronym / sponsor ID
- ProAnest
- Conditions
- Oropharyngeal Microbiology
- Keywords
- Probiotics, Anaesthesia, Intubation, Pathogenic bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Jan 2012
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 31 Jan 2012 (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.
Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.
Healthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal but those do occur among patients, both in those not so sick and patients with more severe problems.
For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this is a pilot study to explore the possibility of the same kind of positive effects in patients due for longer (more than 4 hours of anesthesia) procedures.
Randomisation
- No prophylaxis
- Preparation with a probiotic suspension before intubation.
Cultures
- oropharynx
- before treatment
- after intubation
- before extubation
- day 1 postoperatively
- tracheal secretions
- after intubation
- before extubation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: ProbioticsPatients will gurgle and swallow a mixture of probiotic bacteria |
| Control | No intervention | –No intervention. What has been the standard procedure so far |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Planned interventions
- Anaesthesia > 4 hours and requiring intubation
Key exclusion criteria (4 listed)
- Ulcers in the mouth, oropharynx, oesophagus and stomach
- Current infections in the airways
- Known immuno deficiences
- Emergency cases
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 |
|---|---|---|
| ProbioticsAlso: Lactobacillus plantarum 299, Lactobacillus plantarum 299vPatients will gurgle and swallow a mixture of probiotic bacteria | Dietary supplement | Probiotics |
Primary outcome
Differences in pathogenic bacteria in the oropharynx and lower airways
Time frame: During hospitalization, up to 4 weeks
Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in conection with anaestesia and a surgical intervention
4 secondary outcomes
White blood cells
Time frame: During hospitalization, up to 4 weeks
CRP
Time frame: During hospitalization, up to 4 weeks
Pneumonia
Time frame: Up till 7 days postoperatively
Length of hospital stay
Time frame: time to discharged from hospital or patients death
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 10 Mar 2021.
- Background: PubMed 10909023Stjernquist-Desatnik A, Warfving H, Johansson ML. Persistence of Lactobacillus plantarum DSM 9843 on human tonsillar surface after oral administration in fermented oatmeal gruel. A pilot study. Acta Otolaryngol Suppl. 2000;543:215-9. doi: 10.1080/000164800454422.
- Background: 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.
- Individual participant dataSharing planned: Yes. Results are intended to be published 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.
Bengt klarin, MD PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Oropharyngeal Microbiology, run by Region Skane at 1 site 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 3 inclusion and 4 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Differences in pathogenic bacteria in the oropharynx and lower airways (time frame: During hospitalization, up to 4 weeks). 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 NCT01521650, 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 10 Mar 2021.