Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion
Effect of Probiotics on Microbiome of Adenoid Tissue and Middle Ear Fluid of Children With Otitis Media With Effusion
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2017
CompletedFirst Submitted
Initial submission to the registry
September 7, 2017
CompletedFirst Posted
Study publicly available on registry
September 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedApril 30, 2021
April 1, 2021
4.1 years
September 7, 2017
April 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
4 years
Secondary Outcomes (1)
Differences in absolute concentration of otitis media pathogens
4 years
Study Arms (2)
Probiotic group
EXPERIMENTALIntake of 1 portion (=6 droplets) Probactiol Mini during 4 weeks.
Control group
NO INTERVENTIONNo intake of Probactiol Mini
Interventions
6 droplets of Probactiol Mini contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)
Eligibility Criteria
You may qualify if:
- children with otitis media with effusion
- children with adenoid hypertrophy
You may not qualify if:
- no patients with trisomy 21
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antwerp University Hospital
Edegem, Antwerp, 2650, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Investigator does not know which subjects administered probiotics
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof. dr. An Boudewyns, MD, PhD
Study Record Dates
First Submitted
September 7, 2017
First Posted
September 11, 2017
Study Start
April 3, 2017
Primary Completion
April 30, 2021
Study Completion
April 30, 2021
Last Updated
April 30, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share