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| Name | Class |
|---|---|
| Probi AB | INDUSTRY |
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Hospitalised patients have in contrast to healthy people enteric pathogenic bacteria in their oropharynx Increased risk of pneumonia due to the pathogens in the oropharynx Probiotics can reduce such bacteria in intubated critically ill patients This study will use two strain of probiotic bacteria for half of the patients and a placebo for the rest Active arm gurgles with a suspension twice a day Cultures at inclusion and at set time intervals The results of cultures from the two groups will be compared as will the use of antibiotics
When patients are admitted to hospital some of them are already colonized in the oropharynx with pathogens that are normally found as commensal or possible pathogens in the gastrointestinal tract. This is probably a consequence of the illness that is the cause of their hospital admission.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Active Comparator | Patients gurgle twice a day with a suspension of two probiotic strains of bacteria- Contains also a filling material - maltodextrin |
|
| Control | Placebo Comparator | Patients gurgle twice a day with a suspension of the filling material - maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Cultures from the oropharynx |
|
| Measure | Description | Time Frame |
|---|---|---|
| New appearing pathogenic bacteria in the oropharynx | Oropharyngeal cultures taken at admission and at specified days thereafter in all patients Results from Clin Microbiology assessed and all relevant findings will be treated according to patterns of antibiotic resistance | During hospital stay, Average 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumonia | Appearing health care related pneumonia. Treating physicians at the wards follow the patients condition and progress. Ward physicians prescribes antibiotics and chest x-rays on clinical grounds | During hospital stay, Average 7 days |
| Length of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bengt Klarin, MD, PhD | Lund University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lund University Hospital | Lund | SE-22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4899868 | Background | 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. | |
| 18990201 | Result | 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. |
| Label | URL |
|---|---|
| Producers of the study products | View source |
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Study results will be published as a scientific article
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | Cultures from the oropharynx |
|
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Hospital stay , Days |
| During hospital stay, Average 7 days |
| 33350604 | Derived | 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. |
| D019602 |
| Food and Beverages |