Efficacy of Streptococcus salivarius K12 oral probiotic products in preventing acute otitis media.
Phase 1
- Conditions
- Acute otitis mediaMedDRA version: 20.0Level: LLTClassification code 10033084Term: Otitis media NOSSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2020-001076-14-FI
- Lead Sponsor
- Oulu University Hospital, Oulu, Finland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1000
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
No ongoing antimicrobial prophylaxis or immunosuppression/immunodeficiency.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method