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

NCT ID: NCT03277820

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2021-04-30

Brief Summary

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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

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Conditions

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Otitis Media With Effusion Probiotics Adenoid Vegetations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators
Investigator does not know which subjects administered probiotics

Study Groups

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Probiotic group

Intake of 1 portion (=6 droplets) Probactiol Mini during 4 weeks.

Group Type EXPERIMENTAL

Probactiol Mini

Intervention Type DIETARY_SUPPLEMENT

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

Control group

No intake of Probactiol Mini

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Probactiol Mini

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* children with otitis media with effusion
* children with adenoid hypertrophy

Exclusion Criteria

* no patients with trisomy 21
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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[email protected]

prof. dr. An Boudewyns, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Antwerp University Hospital

Edegem, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B300201731908

Identifier Type: -

Identifier Source: org_study_id

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