An interventional study of Probactiol Mini in Otitis Media With Effusion, Probiotics and Adenoid Vegetations, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Basic science
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.
88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.
This study's enrollment of 37 is below the median of 80 across 61 interventional studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Intake of 1 portion (=6 droplets) Probactiol Mini during 4 weeks.
Dietary Supplement: Probactiol Mini
No intake of Probactiol Mini
6 droplets of Probactiol Mini contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)
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.
Time frame: 4 years
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.
Time frame: 4 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2017 to primary completion in Apr 2021, 48 months.
Of 16 interventional studies with no phase under Otitis Media with Effusion, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 65. This study's 48 months is close to that.
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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