Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
145 participants
INTERVENTIONAL
2014-10-31
2020-07-31
Brief Summary
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Detailed Description
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Most patients admitted to hospital are elderly. Those patients often have their natural functions down regulated including their ability to secure their airway from aspiration. Acute illness whether you are old or young leads to changes in the intestinal microbiological flora. Bacteria normally found in the colon or distal ileum frequently appear in the stomach and more alarming in the oropharynx. Weakened by the illness, acute or chronic, there is an increased risk of aspiration and when there are pathogenic bacteria in the oropharynx, aspiration is likely to induce pneumonia - health related pneumonia.
For intubated ICU patients we have demonstrated a reduction of colonization with enteric bacteria by applying probiotics in the mouth.
After a screening period to find out what groups of patients that are most vulnerable, we will in a randomised way give probiotics to half of the included patients and to the other patients only the filling material (maltodextrin).
With this procedure our aim is to show a reduction of pathogens in the oropharynx and as a secondary outcome we hope to see a reduction of pneumonia.
Samples for microbiological analysis will be taken during the first day of admission to hospital and then at specified intervals.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Study Groups
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Probiotics
Patients gurgle twice a day with a suspension of two probiotic strains of bacteria- Contains also a filling material - maltodextrin
Probiotics
Cultures from the oropharynx
Control
Patients gurgle twice a day with a suspension of the filling material - maltodextrin
Placebo
Cultures from the oropharynx
Interventions
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Probiotics
Cultures from the oropharynx
Placebo
Cultures from the oropharynx
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Anticipated length of hospital stay 3 days or more
Exclusion Criteria
* Prior participation in the study
* Not being able to understand study information
18 Years
ALL
No
Sponsors
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Probi AB
INDUSTRY
Region Skane
OTHER
Responsible Party
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Bengt Klarin
MD Consultant
Principal Investigators
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Bengt Klarin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Lund University Hospital
Locations
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Lund University Hospital
Lund, , Sweden
Countries
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References
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Johanson WG, Pierce AK, Sanford JP. Changing pharyngeal bacterial flora of hospitalized patients. Emergence of gram-negative bacilli. N Engl J Med. 1969 Nov 20;281(21):1137-40. doi: 10.1056/NEJM196911202812101. No abstract available.
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.
Tranberg A, Klarin B, Johansson J, Pahlman LI. Efficacy of Lactiplantibacillus plantarum 299 and 299v against nosocomial oropharyngeal pathogens in vitro and as an oral prophylactic treatment in a randomized, controlled clinical trial. Microbiologyopen. 2021 Jan;10(1):e1151. doi: 10.1002/mbo3.1151. Epub 2020 Dec 22.
Related Links
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Producers of the study products
Other Identifiers
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ProOro
Identifier Type: -
Identifier Source: org_study_id
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