Otitis Media and Nasopharyngeal Microbiome in Children.

Otitis Media and Nasopharyngeal Microbiome in Children. The change of nasopharyngeal microbiome and its role as a risk factor of otitis media. Streptococcus salivarius K12 and the change of nasopharyngeal microbiome.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000820-83-FI

Enrollment

150

Registered

2017-05-12

Start date

2017-07-03

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We investigate role of microbiota as the risk factor of acute otitis media in children. MedDRA version: 20.0 Level: LLT Classification code 10033071 Term: Otitis System Organ Class: 100000004862 MedDRA version: 20.1 Level: LLT Classification code 10069718 Term: Bacterial colonization System Organ Class: 100000004862

Interventions

Trade Name: This product formulation has been designed for this trial and does not have a trade name. Product Name: Streptococcus salivarius K12 strain Pharmaceutical Form: Oral powder in sachet INN o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 1-6 years, in daycare center in the city of Oulu. Are the trial subjects under 18? yes Number of subjects for this age range: 150 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Preventive antibiotic treatment or effusion in the middle ear.

Design outcomes

Primary

Measure	Time frame
Main Objective: We investigate the role of microbiota as a risk factor of acute otitis media in children. We conclude the acceptability and microbial efficiency (change in the microbiome of nasopharyngeal/oral cavity) of two Streptococcus salivarius K12 BLIS products in children.;Secondary Objective: Also we investigate the change in nasopharyngeal and oral microbiota after administering Streptococcus salivarius K12.;Primary end point(s): Primary end point is the positive Streptococcus salivarius quantitative 16S RNA PCR result in time points 1 and 2 months, e.g. after the 1 month use of the product and 1 month after that. Hence we are measuring the rate of S. salivarius colonization, or the microbiological efficiency of the different products. Samples are to be taken from controls as well since we do not know if the bacteria is able to transmit among children, and for how long the desired result lasts.;Timepoint(s) of evaluation of this end point: 1 and 2 months from the beginning of the trial.	—

Measure

Time frame

Main Objective: We investigate the role of microbiota as a risk factor of acute otitis media in children. We conclude the acceptability and microbial efficiency (change in the microbiome of nasopharyngeal/oral cavity) of two Streptococcus salivarius K12 BLIS products in children.;Secondary Objective: Also we investigate the change in nasopharyngeal and oral microbiota after administering Streptococcus salivarius K12.;Primary end point(s): Primary end point is the positive Streptococcus salivarius quantitative 16S RNA PCR result in time points 1 and 2 months, e.g. after the 1 month use of the product and 1 month after that. Hence we are measuring the rate of S. salivarius colonization, or the microbiological efficiency of the different products. Samples are to be taken from controls as well since we do not know if the bacteria is able to transmit among children, and for how long the desired result lasts.;Timepoint(s) of evaluation of this end point: 1 and 2 months from the beginning of the trial.

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Secondary

Measure	Time frame
Secondary end point(s): The relative abundance of Streptococcus salivarius K12 in saliva and pharynx. 16S RNA total bacterial microbiome analysis using next generation sequencing methods. Microbiome diversity and its change in time points 0, 1 and 2 months after recruitment. Existence of common otitis pathogens and possible change in the proportions of pathogens during the trial. Existence of common upper respiratory tract viruses and their possible coexistence with distinct microbiota.;Timepoint(s) of evaluation of this end point: 0, 1 and 2 months after recruitment. A voluntary visit during the first upper respiratory tract infection.	—

Measure

Time frame

Secondary end point(s): The relative abundance of Streptococcus salivarius K12 in saliva and pharynx. 16S RNA total bacterial microbiome analysis using next generation sequencing methods. Microbiome diversity and its change in time points 0, 1 and 2 months after recruitment. Existence of common otitis pathogens and possible change in the proportions of pathogens during the trial. Existence of common upper respiratory tract viruses and their possible coexistence with distinct microbiota.;Timepoint(s) of evaluation of this end point: 0, 1 and 2 months after recruitment. A voluntary visit during the first upper respiratory tract infection.

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Countries

Finland

Contacts

Public ContactPEDEGO/Lasten ja nuorten klinikka

Oulu University Hospital

+35883152011

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026