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

NCT03277820 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-04-30

No results posted yet for this study

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.

Conditions

  • Otitis Media With Effusion
  • Probiotics
  • Adenoid Vegetations

Interventions

DIETARY_SUPPLEMENT

Probactiol Mini

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

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03277820 on ClinicalTrials.gov