Changes of Oropharyngeal Flora

Pneumonia Clinical Trial

Official title:

Changes in the Oropharyngeal Flora in Hospitalised Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303301
• Other study ID #: ProOro
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: July 2020

Study information

• Verified date: October 2020
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pharyngeal Bacterial Colonization
• Pneumonia

Intervention

Dietary Supplement:
• Probiotics
Cultures from the oropharynx
• Placebo
Cultures from the oropharynx

Locations

Country	Name	City	State
Sweden	Lund University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Probi AB

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View 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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Length of hospital stay	Hospital stay , Days	During hospital stay, Average 7 days

External Links

•   Producers of the study products