Clinical trial NCT02303301: Changes of Oropharyngeal Flora
Official title: Changes in the Oropharyngeal Flora in Hospitalised Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharyngeal Bacterial Colonization
Pneumonia
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Probi AB
First posted: 2014-11-27
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Admitted to hospital
* Anticipated length of hospital stay 3 days or more

Exclusion Criteria:

* Immune insufficiency
* Prior participation in the study
* Not being able to understand study information

Primary outcomes:
measure: New appearing pathogenic bacteria in the oropharynx
timeFrame: During hospital stay, Average 7 days
Secondary outcomes:
measure: Pneumonia
timeFrame: During hospital stay, Average 7 days
measure: Length of hospital stay
timeFrame: During hospital stay, Average 7 days
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
affiliation: Lund University Hospital
name: Bengt Klarin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.