Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion

Not Applicable

Completed

• Conditions: Otitis Media With Effusion; Probiotics; Adenoid Vegetations
• Interventions: Dietary Supplement: Probactiol Mini

• Registration Number: NCT03277820
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-03
• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-11
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• children with otitis media with effusion
• children with adenoid hypertrophy

Exclusion Criteria

• no patients with trisomy 21

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	Probactiol Mini	Intake of 1 portion (=6 droplets) Probactiol Mini during 4 weeks.

Primary Outcome Measures

Name	Time	Method
Microbiome differences	4 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.

Secondary Outcome Measures

Name	Time	Method
Differences in absolute concentration of otitis media pathogens	4 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.

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium