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    Summary
    EudraCT Number:2020-001076-14
    Sponsor's Protocol Code Number:K12-2020
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2020-001076-14
    A.3Full title of the trial
    Efficacy of Streptococcus salivarius K12 oral probiotic products in preventing acute otitis media: A randomized placebo-controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Streptococcus salivarius K12 oral probiotic products in preventing acute otitis media.
    A.4.1Sponsor's protocol code numberK12-2020
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOulu University Hospital, Oulu, Finland
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAcademy of Finland, Pediatric Research Foundation Finland, University of Oulu Graduate School
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSuvi Sarlin/Oulu Univ Hosp
    B.5.2Functional name of contact pointSuvi Sarlin
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 23
    B.5.3.2Town/ cityOulu
    B.5.3.4CountryFinland
    B.5.6E-mailsuvi.sarlin@oulu.fi
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Oulu
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAcademy of Finland
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportPediatric Research Foundation Finland
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportUniversity of Oulu Graduate School
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSuvi Sarlin/ Oulu University and Oulu Univ. Hospital
    B.5.2Functional name of contact pointSuvi Sarlin, M.D.
    B.5.3 Address:
    B.5.3.1Street AddressP. O. Box 23
    B.5.3.2Town/ cityOulu
    B.5.3.4CountryFinland
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ToothGuide® Plus
    D.2.1.1.2Name of the Marketing Authorisation holderGutGuide Ltd., Finland
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameToothGuide®
    D.3.4Pharmaceutical form Soluble tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameSTREPTOCOCCUS SALIVARIUS K12
    D.3.9.4EV Substance CodeSUB187241
    D.3.10 Strength
    D.3.10.1Concentration unit billion CFU billion colony forming units
    D.3.10.2Concentration typenot less then
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeProbiotic
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Oral powder in sachet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameSTREPTOCOCCUS SALIVARIUS K12
    D.3.9.4EV Substance CodeSUB187241
    D.3.10 Strength
    D.3.10.1Concentration unit billion CFU billion colony forming units
    D.3.10.2Concentration typenot less then
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeProbiotic
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboChewable tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral powder in sachet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute otitis media
    E.1.1.1Medical condition in easily understood language
    Middle ear infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033084
    E.1.2Term Otitis media NOS
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    Secondary objectives are the proportion of children who have recurrent acute otitis media, time to first AOM, AOM incidence, need of antimicrobial treatment for AOM and any illness and the clinical features of AOM in children. Proportion of children with COVID-19 infection or positive SARS-CoV-2 sample in and the proportion of children who had undergone COVID-19 testing. The proportion of children with any physician appointments due to acute illness. Number of days of parental absenteeism from work due to their child’s illness. The proportion of children with hospitalization due to acute illness and duration of hospitalization. The number and incidence of any AOM episodes per child (including parent reported AOM episodes without antibiotic prescriptions and only antibiotic prescriptions for AOM). Proportion of children with ≥ 1 acute respiratory tract infection or wheezing episodes, number of these episodes and symptom days per child. Time frame is 0-6 months for all outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 1-6 years, attending City of Oulu day care or a sibling of a child attending day care. Written informed consent.
    E.4Principal exclusion criteria
    No ongoing antimicrobial prophylaxis or immunosuppression/immunodeficiency.
    E.5 End points
    E.5.1Primary end point(s)
    • The proportion of children with at least one AOM episode requiring antimicrobial treatment in 0-6 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly questionnaires and the end of the study (=6 months follow-up).
    E.5.2Secondary end point(s)
    The proportion of children with a recurring AOM episode requiring antimicrobial treatment in 0-6 months, i.e. at least 3 AOM episodes in 0-6 months
    Time to the first AOM episode requiring antimicrobial treatment during the intervention until 6 months
    The incidence density of all AOM episodes diagnosed by physician (episodes of AOM per PYR) in 0-6 months
    The proportion of children with any antimicrobial treatment in 0-6 months
    The proportion of children with any physician appointments due to acute illness 0-6 months
    The number of new acute respiratory infections (ARI) in 0-6 months
    Number of days of parental absenteeism from work due to their child’s illness in 0-6 months
    The proportion of children with hospitalization due to acute respiratory illness in 0-6 months and duration of hospitalization
    Proprortion of children with COVID-19 infection or positive SARS-CoV-2 sample in 0-6 months
    Proportion of children with at least one respiratory tract infection episode in 0-6 months
    Proportion of children who had undergone COVID-19 testing in 0-6 months
    The number of any AOM episodes per child (including parent reported AOM episodes without antibiotic prescriptions) in 0-6 months
    Proportion of children with ≥ 1 acute respiratory tract infection episodes in 0-6 months
    Number of acute respiratory tract symptom days per child in 0-6 months
    The proportion of children with hospitalization due to acute respiratory illness in 0-6 months and duration of hospitalization for any acute reason
    Proportion of children with ≥ 1 parent reported wheezing episodes in 0-6 months
    Incidence of acute AOM episodes measured as verified and purchased antibiotic prescriptions in 0-6 months
    Incidence of acute AOM episodes measured as parent reported episodes or AOM episodes that passed with watchful waiting and verified antibiotic prescriptions in 0-6 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monthly questionnaires and the end of the study (=6 months follow-up).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Intervention and follow up 6 months from Aug-Oct 2020 to Feb-May 2021
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1000
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 400
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 600
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Underaged children cannot give written informed consent. Thus their parent gives the consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No spesific treatment or care - normal health check-ups.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
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