Skip to main content
OpenTrials
Completed

NCT Number: NCT02303301

Changes of Oropharyngeal Flora

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University Hospital

Lund, SE-22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

Cultures from the oropharynx

Other names: ProViva (Lactobacillus plantarum 299v)

Placebo

Dietary Supplement

Cultures from the oropharynx

Other names: Maltodextrin

Primary outcomes

  1. New appearing pathogenic bacteria in the oropharynx

    Time frame: During hospital stay, Average 7 days

    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

Secondary outcomes

  1. Pneumonia

    Time frame: During hospital stay, Average 7 days

    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

  2. Length of hospital stay

    Time frame: During hospital stay, Average 7 days

    Hospital stay , Days

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Probi AB

Registry information

Official study title

Changes in the Oropharyngeal Flora in Hospitalised Patients

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Nov 27, 2014
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.