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Trial record 26 of 97 for:    Lactobacillus | maltodextrin

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. Identifier: NCT02303301
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : December 27, 2018
Probi AB
Information provided by (Responsible Party):
Bengt Klarin, Region Skane

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

Condition or disease Intervention/treatment Phase
Pharyngeal Bacterial Colonization Pneumonia Dietary Supplement: Probiotics Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02303301

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Contact: Bengt Klarin, MD, PhD +46 46 171941
Contact: Anne Adolfsson, RN +46 46 173805

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Lund University Hospital Recruiting
Lund, Sweden, SE-22185
Contact: Bengt Klarin, MD PhD    +4646171941   
Contact: Anne Adolfsson, RN    +4646173805   
Sub-Investigator: Gustaf Lyytinen, Med student         
Sub-Investigator: Anna Tranberg Lindqvist, MD         
Principal Investigator: Bengt Klarin, MD, PhD         
Sub-Investigator: Hulda Thorarinsdottir, MD         
Sponsors and Collaborators
Region Skane
Probi AB
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Principal Investigator: Bengt Klarin, MD, PhD Lund University Hospital

Publications of Results:
Other Publications:
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Responsible Party: Bengt Klarin, MD Consultant, Region Skane Identifier: NCT02303301     History of Changes
Other Study ID Numbers: ProOro
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study results will be published as a scientific article
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections