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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03277820
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : June 13, 2018
Information provided by (Responsible Party):
Ethisch Comité, UZA, 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.

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Probiotics Adenoid Vegetations Dietary Supplement: Probactiol Mini Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • no patients with trisomy 21

Information from the National Library of Medicine

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 identifier (NCT number): NCT03277820

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Antwerp University Hospital Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: An N Boudewyns, MD, PhD    + 3238213384   
Contact: Marianne FL van den Broek, ir    +3232653217   
Sponsors and Collaborators
University Hospital, Antwerp

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Responsible Party: Ethisch Comité, UZA, prof. dr. An Boudewyns, MD, PhD, University Hospital, Antwerp Identifier: NCT03277820     History of Changes
Other Study ID Numbers: B300201731908
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases