Back to resultsEffect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion
Primary Purpose
Otitis Media With Effusion, Probiotics, Adenoid Vegetations
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Probactiol Mini
Sponsored by
About this trial
This is an interventional basic science trial for Otitis Media With Effusion
Eligibility Criteria
Inclusion Criteria:
- children with otitis media with effusion
- children with adenoid hypertrophy
Exclusion Criteria:
- no patients with trisomy 21
Sites / Locations
- Antwerp University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Probiotic group
Control group
Arm Description
Intake of 1 portion (=6 droplets) Probactiol Mini during 4 weeks.
No intake of Probactiol Mini
Outcomes
Primary Outcome Measures
Microbiome differences
After Illumina MiSeq sequencing, bio-informatic tools will be used to cluster bacteria into operational taxonomic units (OTUs). Based on these OTUs, we will compare the composition of the bacteria in the sampled niches and compare this composition between patient with and without intake of probiotics. We will specifically screen for OTUs that are over- or underrepresented in both populations. Furthermore, special attention will go to screen for the typical nasopharyngeal pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis... and also to beneficial microbes such as lactic acid bacteria.
Secondary Outcome Measures
Differences in absolute concentration of otitis media pathogens
After DNA extraction of the biological samples, the absolute concentration of the administered probiotics and otitis media pathogens will be monitored via qPCR. This will give information about the capacity of the probiotics to colonise the nasopharynx and to alter the concentration of pathogens.
Full Information
NCT ID
NCT03277820
First Posted
September 7, 2017
Last Updated
April 29, 2021
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT03277820
Brief Title
Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion
Official Title
Effect of Probiotics on Microbiome of Adenoid Tissue and Middle Ear Fluid of Children With Otitis Media With Effusion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate whether the microbiota in the upper respiratory tract (nasopharynx, adenoids and middle ear fluid) of otitis media with effusion (OME) patients is changed after 4 weeks of probiotic product intake. Therefore, bacterial DNA from swabs, fluid and tissue will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Furthermore, the concentration of specific pathogens will be monitored via qPCR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion, Probiotics, Adenoid Vegetations
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Investigator does not know which subjects administered probiotics
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
Intake of 1 portion (=6 droplets) Probactiol Mini during 4 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intake of Probactiol Mini
Intervention Type
Dietary Supplement
Intervention Name(s)
Probactiol Mini
Intervention Description
6 droplets of Probactiol Mini contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)
Primary Outcome Measure Information:
Title
Microbiome differences
Description
After Illumina MiSeq sequencing, bio-informatic tools will be used to cluster bacteria into operational taxonomic units (OTUs). Based on these OTUs, we will compare the composition of the bacteria in the sampled niches and compare this composition between patient with and without intake of probiotics. We will specifically screen for OTUs that are over- or underrepresented in both populations. Furthermore, special attention will go to screen for the typical nasopharyngeal pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis... and also to beneficial microbes such as lactic acid bacteria.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Differences in absolute concentration of otitis media pathogens
Description
After DNA extraction of the biological samples, the absolute concentration of the administered probiotics and otitis media pathogens will be monitored via qPCR. This will give information about the capacity of the probiotics to colonise the nasopharynx and to alter the concentration of pathogens.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children with otitis media with effusion
children with adenoid hypertrophy
Exclusion Criteria:
no patients with trisomy 21
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion
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