Efficacy of Streptococcus salivarius K12 oral probiotic products in preventing acute otitis media.

Efficacy of Streptococcus salivarius K12 oral probiotic products in preventing acute otitis media: A randomized placebo-controlled trial.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001076-14-FI

Enrollment

1000

Registered

2020-04-06

Start date

2020-04-20

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

Acute otitis media MedDRA version: 20.0 Level: LLT Classification code 10033084 Term: Otitis media NOS System Organ Class: 100000004862

Interventions

Trade Name: ToothGuide® Plus Product Name: ToothGuide® Pharmaceutical Form: Soluble tablet Other descriptive name: STREPTOCOCCUS SALIVARIUS K12 Concentration unit: billion CFU billion colony forming u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 1-6 years, attending City of Oulu day care or a sibling of a child attending day care. Written informed consent. No middle ear effusion at study entry. Are the trial subjects under 18? yes Number of subjects for this age range: 1000 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: No ongoing antimicrobial prophylaxis or immunosuppression/immunodeficiency.

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective is to investigate the clinical efficacy of Streptococcus salivarius K12 probiotic products in preventing acute otitis media (AOM) in children for 6 months. ;Secondary Objective: Secondary objectives are to assess the proportion of children who have recurrent acute otitis media, time to first AOM, AOM incidence, need of antimicrobial treatment and the clinical features of AOM in children. Proportion of children with a respiratory viral sample, i.e. respiratory symptoms in 0-6 months. Proprortion of children with COVID-19 infection or positive SARS-CoV-2 sample in 0-6 months. Proportion of children with throat swab. Proportion of children with Streptococcus pyogenes infection or positive StrepA culture in 0-6 months in 0-6 months. Proportion of children with other bacterial findings or viral findings in 0-6 months (i.e. wheezing, pneumonia etc.) ;Primary end point(s): The end of the follow-up regardless of how many AOM are diagnosed for each child.;Timepoint(s) of evaluation of this end point: Monthly questionnaires and the end of the study (=6 months follow-up).	—

Measure

Time frame

Main Objective: Main objective is to investigate the clinical efficacy of Streptococcus salivarius K12 probiotic products in preventing acute otitis media (AOM) in children for 6 months. ;Secondary Objective: Secondary objectives are to assess the proportion of children who have recurrent acute otitis media, time to first AOM, AOM incidence, need of antimicrobial treatment and the clinical features of AOM in children. Proportion of children with a respiratory viral sample, i.e. respiratory symptoms in 0-6 months. Proprortion of children with COVID-19 infection or positive SARS-CoV-2 sample in 0-6 months. Proportion of children with throat swab. Proportion of children with Streptococcus pyogenes infection or positive StrepA culture in 0-6 months in 0-6 months. Proportion of children with other bacterial findings or viral findings in 0-6 months (i.e. wheezing, pneumonia etc.) ;Primary end point(s): The end of the follow-up regardless of how many AOM are diagnosed for each child.;Timepoint(s) of evaluation of this end point: Monthly questionnaires and the end of the study (=6 months follow-up).

—

Secondary

Measure	Time frame
Secondary end point(s): Monthly questionnaires and the end of the study (=6 months follow-up). ;Timepoint(s) of evaluation of this end point: Monthly questionnaires and the end of the study (=6 months follow-up).	—

Countries

Finland

Contacts

Public ContactSuvi Sarlin

Suvi Sarlin/Oulu Univ Hosp

suvi.sarlin@oulu.fi

Outcome results

None listed

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