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Changes of Oropharyngeal Flora

Primary Purpose

Pharyngeal Bacterial Colonization, Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Probiotics
Placebo
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pharyngeal Bacterial Colonization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lund University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotics

Control

Arm Description

Patients gurgle twice a day with a suspension of two probiotic strains of bacteria- Contains also a filling material - maltodextrin

Patients gurgle twice a day with a suspension of the filling material - maltodextrin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Length of hospital stay
Hospital stay , Days

Full Information

First Posted
November 25, 2014
Last Updated
October 6, 2020
Sponsor
Region Skane
Collaborators
Probi AB
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1. Study Identification

Unique Protocol Identification Number
NCT02303301
Brief Title
Changes of Oropharyngeal Flora
Official Title
Changes in the Oropharyngeal Flora in Hospitalised Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
Collaborators
Probi AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngeal Bacterial Colonization, Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Active Comparator
Arm Description
Patients gurgle twice a day with a suspension of two probiotic strains of bacteria- Contains also a filling material - maltodextrin
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients gurgle twice a day with a suspension of the filling material - maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Other Intervention Name(s)
ProViva (Lactobacillus plantarum 299v)
Intervention Description
Cultures from the oropharynx
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Maltodextrin
Intervention Description
Cultures from the oropharynx
Primary Outcome Measure Information:
Title
New appearing pathogenic bacteria in the oropharynx
Description
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
Time Frame
During hospital stay, Average 7 days
Secondary Outcome Measure Information:
Title
Pneumonia
Description
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
Time Frame
During hospital stay, Average 7 days
Title
Length of hospital stay
Description
Hospital stay , Days
Time Frame
During hospital stay, Average 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bengt Klarin, MD, PhD
Organizational Affiliation
Lund University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
SE-22185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results will be published as a scientific article
Citations:
PubMed Identifier
4899868
Citation
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. doi: 10.1056/NEJM196911202812101. No abstract available.
Results Reference
background
PubMed Identifier
18990201
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. Epub 2008 Nov 6.
Results Reference
result
PubMed Identifier
33350604
Citation
Tranberg A, Klarin B, Johansson J, Pahlman LI. Efficacy of Lactiplantibacillus plantarum 299 and 299v against nosocomial oropharyngeal pathogens in vitro and as an oral prophylactic treatment in a randomized, controlled clinical trial. Microbiologyopen. 2021 Jan;10(1):e1151. doi: 10.1002/mbo3.1151. Epub 2020 Dec 22.
Results Reference
derived
Links:
URL
http://www.probi.se
Description
Producers of the study products

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Changes of Oropharyngeal Flora

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