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Completed

NCT Number: NCT03277820

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

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.

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Key information

Conditions

OTITIS MEDIA WITH EFFUSION Adenoid Vegetations Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases Probiotics

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no patients with trisomy 21

Treatment and study plan

Probactiol Mini

Dietary Supplement

6 droplets of Probactiol Mini contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)

Primary outcomes

  1. Microbiome differences

    Time frame: 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 outcomes

  1. Differences in absolute concentration of otitis media pathogens

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Effect of Probiotics on Microbiome of Adenoid Tissue and Middle Ear Fluid of Children With Otitis Media With Effusion

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2017
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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