Changes of Oropharyngeal Flora
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02303301|
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : December 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pharyngeal Bacterial Colonization Pneumonia||Dietary Supplement: Probiotics Dietary Supplement: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Changes in the Oropharyngeal Flora in Hospitalised Patients|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||July 2019|
Active Comparator: Probiotics
Patients gurgle twice a day with a suspension of two probiotic strains of bacteria- Contains also a filling material - maltodextrin
Dietary Supplement: Probiotics
Cultures from the oropharynx
Other Name: ProViva (Lactobacillus plantarum 299v)
Placebo Comparator: Control
Patients gurgle twice a day with a suspension of the filling material - maltodextrin
Dietary Supplement: Placebo
Cultures from the oropharynx
Other Name: Maltodextrin
- 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
- 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
- Length of hospital stay [ Time Frame: During hospital stay, Average 7 days ]Hospital stay , Days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303301
|Contact: Bengt Klarin, MD, PhD||+46 46 171941||Bengt.Klarin@med.lu.se|
|Contact: Anne Adolfsson, RN||+46 46 email@example.com|
|Lund University Hospital||Recruiting|
|Lund, Sweden, SE-22185|
|Contact: Bengt Klarin, MD PhD +4646171941 Bengt.Klarin@med.lu.se|
|Contact: Anne Adolfsson, RN +4646173805 firstname.lastname@example.org|
|Sub-Investigator: Gustaf Lyytinen, Med student|
|Sub-Investigator: Anna Tranberg Lindqvist, MD|
|Principal Investigator: Bengt Klarin, MD, PhD|
|Sub-Investigator: Hulda Thorarinsdottir, MD|
|Principal Investigator:||Bengt Klarin, MD, PhD||Lund University Hospital|