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

Antwerp University Hospital (UZA)

Status: Completed

Conditions: Otitis Media With Effusion; Adenoid Vegetations; Probiotics

Treatments: Dietary Supplement: Probactiol Mini

Study type: Interventional

Funder types: Other

Identifiers

NCT03277820

B300201731908

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• no patients with trisomy 21

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 2 patient groups

Probiotic group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probactiol Mini

Control group

No Intervention group

Description:

No intake of Probactiol Mini