Advanced ENT SurgeryNCT01730066
Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery
A study testing L. plantarum 299 and L. plantarum 299v (+maltodextrin) in people with Advanced ENT Surgery and Microbiological Flora in the Oropharynx and Lower Airways, run by Region Skane at 1 site in Sweden.
Trial summary
Surgery in the mouth and oropharynx is performed in an area colonised by bacteria non-pathogenic and pathogenic. Antibiotics are used regularly resulting in disturbances in the intestinal microbiological flora and consequently diarrhoea that can be troublesome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced ENT Surgery, Microbiological Flora in the Oropharynx and Lower Airways
- What is being tested?
- L. plantarum 299 and L. plantarum 299v (+maltodextrin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to Jun 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
- Elective advanced and extensive ENT surgery
- Adult patients (≥ 18 years)
- Surgery requires general anesthesia and endotracheal intubation
- Length of anesthesia ≥ 1,5 hours
- Signed informed consent
Who cannot join
- Ongoing treatment requiring infection in the lower respiratory tract
- Chronic lung disease requiring oxygen treatment
- Known immune deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics for Reduction of Pathogenic Bacteria in Connection With Advanced Surgery in the Mouth, the Oropharynx, and on the Neck
Surgery in the mouth and oropharynx is performed in an area colonised by bacteria non-pathogenic and pathogenic.
Antibiotics are used regularly resulting in disturbances in the intestinal microbiological flora and consequently diarrhoea that can be troublesome. The use of antibiotics throughout the hospital stay for these difficult cases represent a risk of development of resistant strains.
Read more
Most of the patients have cancer diagnoses and have radiation therapy before surgery. This increases the risk of the patients having pathogenic bacteria normally present in the lower GI-tract.
The investigators have shown for ICU patients that treatment with probiotics reduces the number of emerging enteral bacteria in the oropharynx and now the investigators will perform an adjusted procedure for patients planned for large ear, nose, and throat (ENT) surgery.
Patients will preoperatively gurgle a suspension of probiotics and then swallow the preparation.
Postoperatively the probiotics is given enterally and a eventually by mouth again.
Cultures will be taken from the oropharynx and tracheal secretions and the results will be compared
Read the detailed description
Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.
Surgery including the mouth and the oropharynx is performed in an area that is colonised by hundreds of different bacterial species. In the healthy person there is a balance between the different microbes and possible pathogens are kept under control.
Patients that are subject to surgery in the mouth, oropharynx or neck area, most often have cancer diagnoses. Preoperative treatment (mostly radiation) is done in most cases resulting in a changed spectrum of bacteria in the mouth and oropharynx. Due to lowered appetite increased difficulties to eat, in combination with cancer diagnosis, there is also a change in cranial direction of the microbiological gut flora resulting in the presence of pathogens such as Gram-negative bacteria. Those species may result in troublesome infections in the postoperative period.
With healthy people pathogenic bacteria originating from the gastro/intestinal canal are seldom found in the oropharynx, but those do occur among many patients.
Antibiotics are used prophylactic and for more extensive surgery, as micro vascular procedures with free transplants of tissues, antibiotics are kept throughout the length of stay (LOS) in hospital. This results in an increased risk for the development of resistant bacteria and does result in changes in the GI flora in those patients. Diarrhoea occurs frequently and are troublesome for the patients For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this study will explore the possibility of the same kind of positive effects in patients due for extensive surgery performed during several hours.
Many of the patients will have a tracheostomy performed as part of the surgical procedure.
Patients will be randomised (1:1) to either no prophylaxis (standard procedure today) or to preparation with a probiotic suspension fro the day before surgery until discharge from hospital.
Preoperatively the patients will gurgle a suspension of probiotics and then swallow the preparation.
Postoperatively the probiotics is given enterally and a eventually when the responsible surgeon find it suitable by mouth again.
Cultures at inclusion, after intubation, and then on predefined days postoperatively to compare bacterial flora in the oropharynx and in tracheal secretions.
Infectious parameters will be followed.
- Being tested
- L. plantarum 299 and L. plantarum 299v (+maltodextrin)
- Keywords
- Probiotics, Pathogenic enteric bacteria, Oropharyngeal flora, CRP, WBC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. plantarum 299 and L. plantarum 299v (+maltodextrin)Dietary supplement
Patients will be given a mixture of maltodextrin ( a starch product often used i alimentary products) and two strains of probiotic bacteria ( L. plantarum 299 and L. plantarum 299v ) dissolved in water. They will gurgle and swallow the suspension from the day before surgery. Postoperatively they will be given the probiotic mixture via a nasogastric tubing twice a day and when the responsible surgeon find it suitable also orally as described above. When they can swallow no study product is given through the nasogastric tube.
Patients randomized 1:1 between groups
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Patients will gurgle and swallow a mixture of probiotic bacteria preoperatively and given the same study product enterally postoperatively Receives: Dietary Supplement: L. plantarum 299 and L. plantarum 299v (+maltodextrin) |
| 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
Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in connection to a surgical intervention and postoperatively
Measured: During hospitalization, anticipated mean time 12 days
Secondary outcomes (5)
White Blood Cell count
WBC taken pre-op and then on predefined days postoperatively
Measured: During hospital stay, expected mean LOS 12 days
C Reactive Protein
CRP taken pre-op and then on predefined days postoperatively
Measured: Throughout the hospital stay, expected mean LOS 12 days
Length of Hospital stay
Length of stay is recorded for the Hospital stay, and for those cases that have an extended post-operative period in the ICU, the length of the ICU stay will be recorded
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2-3 weeks
Survival
For participating patients the status of survival or non survival at days 28 and 180 (six months) will be recorded
Measured: Six months
Diarrhoea and obstipation
As ICU patients tend to display diarrhoea as well as obstipation the frequency and consistency of stools will be recorded.
Probiotics are anticipated to stabilise bowel function
Measured: Throughout the hospital stay, expected mean LOS 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2019
- Study completionJun 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 Advanced ENT SurgeryStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Bengt Klarin, MD, PhD, Principal investigator, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730066
- Sponsor's protocol ID
- ProOncENT
- Status last verified
- Oct 2020
- First submitted
- 8 Nov 2012
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Results will 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 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Reduction of Pathogenic Bacteria in Connection With Advanced Surgery in the Mouth, the Oropharynx, and on the Neck
- ClinicalTrials.gov ID
- NCT01730066
- Acronym / sponsor ID
- ProOncENT
- Keywords
- Probiotics, Pathogenic enteric bacteria, Oropharyngeal flora, CRP, WBC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 21 Nov 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.
Surgery in the mouth and oropharynx is performed in an area colonised by bacteria non-pathogenic and pathogenic.
Antibiotics are used regularly resulting in disturbances in the intestinal microbiological flora and consequently diarrhoea that can be troublesome. The use of antibiotics throughout the hospital stay for these difficult cases represent a risk of development of resistant strains.
Most of the patients have cancer diagnoses and have radiation therapy before surgery. This increases the risk of the patients having pathogenic bacteria normally present in the lower GI-tract.
The investigators have shown for ICU patients that treatment with probiotics reduces the number of emerging enteral bacteria in the oropharynx and now the investigators will perform an adjusted procedure for patients planned for large ear, nose, and throat (ENT) surgery.
Patients will preoperatively gurgle a suspension of probiotics and then swallow the preparation.
Postoperatively the probiotics is given enterally and a eventually by mouth again.
Cultures will be taken from the oropharynx and tracheal secretions and the results will be compared
Detailed description
Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.
Surgery including the mouth and the oropharynx is performed in an area that is colonised by hundreds of different bacterial species. In the healthy person there is a balance between the different microbes and possible pathogens are kept under control.
Patients that are subject to surgery in the mouth, oropharynx or neck area, most often have cancer diagnoses. Preoperative treatment (mostly radiation) is done in most cases resulting in a changed spectrum of bacteria in the mouth and oropharynx. Due to lowered appetite increased difficulties to eat, in combination with cancer diagnosis, there is also a change in cranial direction of the microbiological gut flora resulting in the presence of pathogens such as Gram-negative bacteria. Those species may result in troublesome infections in the postoperative period.
With healthy people pathogenic bacteria originating from the gastro/intestinal canal are seldom found in the oropharynx, but those do occur among many patients.
Antibiotics are used prophylactic and for more extensive surgery, as micro vascular procedures with free transplants of tissues, antibiotics are kept throughout the length of stay (LOS) in hospital. This results in an increased risk for the development of resistant bacteria and does result in changes in the GI flora in those patients. Diarrhoea occurs frequently and are troublesome for the patients For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this study will explore the possibility of the same kind of positive effects in patients due for extensive surgery performed during several hours.
Many of the patients will have a tracheostomy performed as part of the surgical procedure.
Patients will be randomised (1:1) to either no prophylaxis (standard procedure today) or to preparation with a probiotic suspension fro the day before surgery until discharge from hospital.
Preoperatively the patients will gurgle a suspension of probiotics and then swallow the preparation.
Postoperatively the probiotics is given enterally and a eventually when the responsible surgeon find it suitable by mouth again.
Cultures at inclusion, after intubation, and then on predefined days postoperatively to compare bacterial flora in the oropharynx and in tracheal secretions.
Infectious parameters will be followed.
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: L. plantarum 299 and L. plantarum 299v (+maltodextrin)Patients will gurgle and swallow a mixture of probiotic bacteria preoperatively and given the same study product enterally postoperatively |
| 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 (5 listed)
- Elective advanced and extensive ENT surgery
- Adult patients (≥ 18 years)
- Surgery requires general anesthesia and endotracheal intubation
- Length of anesthesia ≥ 1,5 hours
- Signed informed consent
Key exclusion criteria (3 listed)
- Ongoing treatment requiring infection in the lower respiratory tract
- Chronic lung disease requiring oxygen treatment
- Known immune deficiency
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 |
|---|---|---|
| L. plantarum 299 and L. plantarum 299v (+maltodextrin)Patients will be given a mixture of maltodextrin ( a starch product often used i alimentary products) and two strains of probiotic bacteria ( L. plantarum 299 and L. plantarum 299v ) dissolved in water. They will gurgle and swallow the suspension from the day before surgery. Postoperatively they will be given the probiotic mixture via a nasogastric tubing twice a day and when the responsible surgeon find it suitable also orally as described above. When they can swallow no study product is given through the nasogastric tube. Patients randomized 1:1 between groups | Dietary supplement | Probiotics |
Primary outcome
Differences in pathogenic bacteria in the oropharynx
Time frame: During hospitalization, anticipated mean time 12 days
Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in connection to a surgical intervention and postoperatively
5 secondary outcomes
White Blood Cell count
Time frame: During hospital stay, expected mean LOS 12 days
C Reactive Protein
Time frame: Throughout the hospital stay, expected mean LOS 12 days
Length of Hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2-3 weeks
Survival
Time frame: Six months
Diarrhoea and obstipation
Time frame: Throughout the hospital stay, expected mean LOS 12 days
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 12 Oct 2020.
- 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.
- Provider of study productLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Results will 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 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. plantarum 299 and L. plantarum 299v (+maltodextrin) in people with Advanced ENT Surgery and Microbiological Flora in the Oropharynx and Lower Airways, 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 5 inclusion and 3 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 12 Oct 2020. 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 (time frame: During hospitalization, anticipated mean time 12 days). 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 NCT01730066, 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 12 Oct 2020.