NCT02303301

Changes of Oropharyngeal Flora

Changes in the Oropharyngeal Flora in Hospitalised Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pharyngeal Bacterial Colonization
• Pneumonia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics	Cultures from the oropharynx
DIETARY_SUPPLEMENT	Placebo	Cultures from the oropharynx

Timeline

• Start date: 2014-10-01
• Primary completion: 2019-03-01
• Completion: 2020-07-01
• First posted: 2014-11-27
• Last updated: 2020-10-08

Locations

1 site across 1 country: Sweden