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    Summary
    EudraCT Number:2017-000820-83
    Sponsor's Protocol Code Number:NNL-2017
    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:2017-05-12
    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 number2017-000820-83
    A.3Full title of the trial
    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.
    Lasten korvatulehdus ja nenännielun mikrobiomi. Nenänielun mikrobiomin koostumus päiväkotilapsilla ja sen merkitys korvatulehduksen riskitekijänä. Streptococcus salivarius K12 ja nenänielun mikrobiomin muutos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Otitis Media and Nasopharyngeal Microbiome in Children.
    Lasten korvatulehdus ja nenännielun mikrobiomi.
    A.4.1Sponsor's protocol code numberNNL-2017
    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 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 supportLastentautien tutkimussäätiö (projektiapuraha)
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportStiftelsen Alma och K. A. Snellman Säätiö (henkilökohtainen tutkimusapuraha)
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOulu University Hospital
    B.5.2Functional name of contact pointPEDEGO/Lasten ja nuorten klinikka
    B.5.3 Address:
    B.5.3.1Street AddressPL 23
    B.5.3.2Town/ cityOulu
    B.5.3.3Post code90029
    B.5.3.4CountryFinland
    B.5.4Telephone number+35883152011
    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 This product formulation has been designed for this trial and does not have a trade name.
    D.2.1.1.2Name of the Marketing Authorisation holderGutguide & Verso Ltd
    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 nameStreptococcus salivarius K12 strain
    D.3.4Pharmaceutical form Oral powder in sachet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    Oromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNStreptococcus salivarius K12
    D.3.9.3Other descriptive nameSTREPTOCOCCUS SALIVARIUS
    D.3.9.4EV Substance CodeSUB126211
    D.3.10 Strength
    D.3.10.1Concentration unit billion CFU billion colony forming units
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5
    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) Yes
    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 No
    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 Yes
    D.2.1.1.1Trade name ToothGuide® Aikuiset Plus Product has a marketing authorisation, but not the same status as medications, hence it does not have ATC codes etc. ToothGuide® is currently in pharmacies as an over-the-counter probiotic product.
    D.2.1.1.2Name of the Marketing Authorisation holderGutguide & Verso Ltd
    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® Aikuiset plus
    D.3.4Pharmaceutical form Chewable/dispersible tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Oromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNStreptococcus salivarius K12
    D.3.9.3Other descriptive nameSTREPTOCOCCUS
    D.3.9.4EV Substance CodeSUB120451
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLACTOBACILLUS RHAMNOSUS SP1
    D.3.9.1CAS number L04001-00-0
    D.3.9.3Other descriptive nameLACTOBACILLUS RHAMNOSUS
    D.3.9.4EV Substance CodeSUB30311
    D.3.10 Strength
    D.3.10.1Concentration unit mCi/mg millicurie(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Yes
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    We investigate role of microbiota as the risk factor of acute otitis media in children.
    Tutkimme nenänielun mikrobiomin yhteyttä korvatulehdusten sairastavuuteen.
    E.1.1.1Medical condition in easily understood language
    Nasopharyngeal microbiome and otitis media in children.
    Nenänielun mikrobiomi ja lasten korvatulehdus.
    E.1.1.2Therapeutic area Body processes [G] - Microbiological Phenomena [G06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033071
    E.1.2Term Otitis
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10069718
    E.1.2Term Bacterial colonization
    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
    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.
    Tutkimme nenänielun mikrobiomin vaikutusta korvatulehdussairastavuuteen. Selvitämme, muuttaako oraalinen S. salivarius nenänielun mikrobiomia, eli kolonisoiko se nenänielun. Tutkimme kahden Streptococcus salivarius K12 BLIS valmisteen käytön helppoutta ja tehokkuutta 1-6v ikäisillä lapsilla.
    E.2.2Secondary objectives of the trial
    Also we investigate the change in nasopharyngeal and oral microbiota after administering Streptococcus salivarius K12.
    Tutkimme nenänielun ja suun mikrobiomin muutosta Streptococcus salivarius K12-valmisteen antamisen jälkeen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 1-6 years, in daycare center in the city of Oulu.
    Ikä 1-6 vuotta, päiväkotihoidossa Oulun kaupungissa.
    E.4Principal exclusion criteria
    Preventive antibiotic treatment or effusion in the middle ear.
    Antibioottiestohoito tai välikorvaerite.
    E.5 End points
    E.5.1Primary 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.
    Päävastemuuttuja on positiivinen Streptococcus salivarius K12-kvantitatiivinen PCR tulos nenänielunäytteissä ajankohdissa 1 ja 2 kk eli kuinka moni lapsista kolonisoituu merkittävästi kummassakin ryhmässä. Selvitämme siis tutkimusvalmisteiden mikrobiologisen tehokkuuden. Otamme näytteet myös verrokeilta.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 and 2 months from the beginning of the trial.
    1 ja 2 kk tutkimuksen aloituksesta.
    E.5.2Secondary 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.
    Streptococcus salivarius K12-suhteellinen osuus ajankohdissa 1 ja 2 kk syljessä ja nenänielussa.
    16S RNA-mikrobiomi –kokonaisanalyysi syljen ja nenänielun näytteistä ajankohdissa 0, 1 ja 2 kk NGS-menetelmiä käyttäen.
    Tyypillisten otiittipatogeenien esiintyminen mikrobiomissa ja niiden esiintymisen mahdollinen muutos. Tavallisimpien ylähengitystievirusten esiintyminen ja mahdollinen yhteys tietyn tyyppiseen mikrobiomiin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    0, 1 and 2 months after recruitment. A voluntary visit during the first upper respiratory tract infection.
    0, 1 ja 2 kk tutkimuksen aloittamisen jälkeen sekä ensimmäisen hengitystieinfektion yhteydessä (vapaaehtoinen).
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ei hoitoa.
    No treatment.
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The 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
    The follow-up ends as the last Webropol-query is sent via email to the participants. The follow-up lasts for one year as we hope to achieve as much information as possible about the incidence of acute otitis media and other upper respiratory tract infections.
    Seuranta-aika on kokonaisuudessaan 1 v. Tutkittavien viimeinen käynti on 2 kk tutkimuksen alkamisesta, mutta seuranta jatkuu Webropol-kyselyin yhteen vuoteen saakka.
    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: 150
    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: 40
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 110
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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
    Children, ages 1-6.
    Lapset iältään 1-6 v.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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)
    None.
    -
    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 Decision2017-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
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