Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion
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|ClinicalTrials.gov Identifier: NCT03277820|
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : June 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media With Effusion Probiotics Adenoid Vegetations||Dietary Supplement: Probactiol Mini||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Investigator does not know which subjects administered probiotics|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Probiotics on Microbiome of Adenoid Tissue and Middle Ear Fluid of Children With Otitis Media With Effusion|
|Actual Study Start Date :||April 3, 2017|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Experimental: Probiotic group
Intake of 1 portion (=6 droplets) Probactiol Mini during 4 weeks.
Dietary Supplement: Probactiol Mini
6 droplets of Probactiol Mini contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)
No Intervention: Control group
No intake of Probactiol Mini
- Microbiome differences [ Time Frame: 2 years ]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.
- Differences in absolute concentration of otitis media pathogens [ Time Frame: 2 years ]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.
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 ClinicalTrials.gov identifier (NCT number): NCT03277820
|Antwerp University Hospital||Recruiting|
|Edegem, Antwerp, Belgium, 2650|
|Contact: An N Boudewyns, MD, PhD + 3238213384 email@example.com|
|Contact: Marianne FL van den Broek, ir +3232653217 firstname.lastname@example.org|