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Changes of Oropharyngeal Flora

Changes in the Oropharyngeal Flora in Hospitalised Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02303301
Enrollment
145
Registered
2014-11-27
Start date
2014-10-31
Completion date
2020-07-31
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharyngeal Bacterial Colonization, Pneumonia

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.

Interventions

DIETARY_SUPPLEMENTProbiotics

Cultures from the oropharynx

DIETARY_SUPPLEMENTPlacebo

Cultures from the oropharynx

Sponsors

Probi AB
CollaboratorINDUSTRY
Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
New appearing pathogenic bacteria in the oropharynxDuring hospital stay, Average 7 daysOropharyngeal 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

Secondary

MeasureTime frameDescription
PneumoniaDuring hospital stay, Average 7 daysAppearing 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
Length of hospital stayDuring hospital stay, Average 7 daysHospital stay , Days

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026