Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-000970-10
    Sponsor's Protocol Code Number:LPS16140
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-07-10
    Trial results View 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-000970-10
    A.3Full title of the trial
    Phase III, randomized, double blind, parallel groups, clinical trial to evaluate the efficacy and safety of Bacillus clausii versus placebo in the prevention of antibiotic associated diarrhea (AAD) in children
    III. fázisú, randomizált, kettős vak, párhuzamos csoportos klinikai vizsgálat gyermekek körében a Bacillus clausii placebóval szembeni hatásosságának és biztonságosságának értékelésére az antibiotikum-kezeléshez társuló hasmenés (AAD) megelőzésében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bacillus clausii in prevention of antibiotic associated diarrhea (AAD) in children
    Bacillus clausii az antibiotikum-kezeléshez társuló hasmenés (AAD) megelőzésében
    A.3.2Name or abbreviated title of the trial where available
    EPIC
    EPIC
    A.4.1Sponsor's protocol code numberLPS16140
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1223-4563
    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 SponsorSanofi Aventis Groupe
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi Aventis Groupe
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Zrt.
    B.5.2Functional name of contact pointna
    B.5.3 Address:
    B.5.3.1Street AddressTó utca 1-5.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1045
    B.5.3.4CountryHungary
    B.5.4Telephone number+3615050050
    B.5.5Fax number+3615052917
    B.5.6E-mailkapcsolat@sanofi.com
    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 No
    D.2.1.1.1Trade name Enterogermina/Normaflore Extra
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 nameEnterogermina/Normaflore Extra
    D.3.2Product code SSR29263
    D.3.4Pharmaceutical form Oral suspension
    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.3.8INN - Proposed INNBacillus clausii
    D.3.9.2Current sponsor codeSSR29263
    D.3.9.3Other descriptive nameBACILLUS CLAUSII
    D.3.9.4EV Substance CodeSUB88746
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms billion organisms
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral suspension
    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
    Antibiotic associated diarrhea (AAD) in children
    Antibiotikum-kezeléshez társuló hasmenés (AAD) gyermekekben
    E.1.1.1Medical condition in easily understood language
    Antibiotic associated diarrhea (AAD) in children
    Antibiotikum-kezeléshez társuló hasmenés (AAD) gyermekekben
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10064065
    E.1.2Term Prophylaxis against diarrhoea
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of Bacillus clausii versus placebo in prevention of AAD in children in an outpatient setting
    A Bacillus clausii placeboval szembeni hatásosságának értékelése az AAD megelőzésében gyermekgyógyászati járóbeteg szakellátás keretében.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of Bacillus clausii versus placebo on prevention of abdominal signs/symptoms (other than diarrhea) associated with antibiotics such as abdominal swelling (belly tension), and vomiting

    To evaluate the efficacy of Bacillus clausii versus placebo on prevention of infectious diarrhea (diagnosis based on positive tests)

    To evaluate the efficacy of Bacillus clausii versus placebo on prevention of hospitalization to manage diarrhea, or prevention of (intravenous) rehydration

    To evaluate the safety of Bacillus clausii.
    A Bacillus clausii hatásosságának értékelése a placebóval szemben az antibiotikum szedéshez kapcsolódó (nem hasmenéses) hasi jelek/tünetek, mint például a haspuffadás (hasfeszülés) és hányás megelőzésében.

    A Bacillus clausii hatásosságának értékelése placebóval szemben a fertőző hasmenés megelőzésében (pozitív teszteken alapuló diagnózis).

    A Bacillus clausii hatásosságának értékelése a placebóval szemben a hasmenés kezelésére szolgáló kórházi felvétel vagy az (intravénás [IV]) rehidratálás megelőzésében.

    A Bacillus clausii biztonságosságának értékelése.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Children must be 3 months to 5 years of age inclusive, at the time of signing the informed consent.

    Children who have to start a short-term (3 to 10 days) treatment with oral antibiotics (broad spectrum beta-lactam AB [amoxicillin-with or without clavulanic acid-, or second and third generation of cephalosporines], or macrolides [erythromycin, clarithromycin, roxithromycin and azithromycin])

    Participant’s legally authorized representative capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
    A gyermekek életkora 3 hónap – 5 év (a szélső értékeket is beleértve) a tájékoztatás utáni beleegyező nyilatkozat aláírásának időpontjában

    Olyan gyermekek, akiknél rövid távú (3-10 napos) kezelést kell indítani orális antibiotikumokkal (széles spektrumú béta-laktám AB [amoxicillin - klavulánsavval vagy anélkül, vagy a cefalosporinok második és harmadik generációja] vagy makrolidokkal [eritromicin, klaritromicin, roxitromicin és azitromicin]).

    A résztvevő jogi képviselője képes aláírt, beleegyező nyilatkozatot adni, amely magában foglalja a szülőnek/gyámnak szóló tájékoztatóban és a protokollban felsorolt követelményeknek és korlátozásoknak való megfelelést.
    E.4Principal exclusion criteria
    Chronic or acute diarrheal disease at the time of enrollment in the study.

    Immunodeficient children or children under immunosuppressive treatment.

    Children requiring hospitalization.

    Chronic GI problems (e.g., short gut syndrome, inflammatory bowel disease, gastroesophageal reflux).

    Severely malnourished participants (children will be considered as severely malnourished if below 70% of the expected weight for age).

    Chronic diseases of endocrine, cardiovascular, renal or respiratory system or any other clinically significant condition that can jeopardize participant’s condition or study outcomes as judged by the Investigator.

    Treatment with probiotics or prebiotics within a period of 2 weeks before enrollment.

    Use of laxatives within one week before enrollment in the study.

    Oral or intravenous antibiotic treatment within 4 weeks before enrollment in the study.
    Krónikus vagy akut hasmenéses betegség a vizsgálatba való beválasztás időpontjában.

    Immunhiányos gyermekek vagy immunszuppresszív kezelés alatt álló gyermekek.

    Kórházi ápolást igénylő gyermekek.

    Krónikus GI-problémák (pl. rövidbél szindróma, gyulladásos bélbetegség, gastroesophagealis reflux).

    Súlyosan alultáplált résztvevők (a gyermekeket súlyosan alultápláltnak kell tekinteni, ha az életkorában elvárható súlyának 70%-a alatt van

    Endokrin, szív- és érrendszeri, vese- vagy légzőrendszer krónikus betegségei vagy bármely egyéb klinikailag jelentős kórállapot, amely a vizsgáló megítélése szerint veszélyeztetheti a résztvevő állapotát vagy a vizsgálati eredményeket.

    Probiotikumokkal vagy prebiotikumokkal történő kezelés a beválasztást megelőző 2 héten belül

    Hashajtók használata a vizsgálatba való beválasztást megelőző egy héten belül.

    Orális vagy intravénás antibiotikumos kezelés a vizsgálatba való beválasztás megelőző 4 héten belül.
    E.5 End points
    E.5.1Primary end point(s)
    Antibiotic Associated Diarrhea occurrence - Percentage of patients with Antibiotic Associated Diarrhea
    Antibiotikum-kezeléshez társuló hasmenés - Antibiotikum-kezeléshez társuló hasmenésben szenvedő betegek százalékos aránya
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Randomization up to 2 weeks after the end of antibiotic therapy
    Randomizálástól kezdve az antibiotikum terápia befejezését követő max. 2 hétig
    E.5.2Secondary end point(s)
    Abdominal signs/symptoms - Percentage of participant with any of the abdominal signs/symptoms

    Abdominal swelling (belly tension) - Percentage of participants with abdominal swelling (belly tension)

    Vomiting - Percentage of participants with vomiting

    Infectious diarrhea - Percentage of patients with Infectious diarrhea

    Hospitalization to manage diarrhea or (intravenous) rehydration - Percentage of participant with hospitalization to manage diarrhea or (intravenous) rehydration.

    Adverse events - Percentage of participants with adverse events
    hasi jel/tünet - azon résztvevők százalékos aránya, akiknél bármilyen hasi jel/tünet jelentkezett

    haspuffadás (hasfeszülés) - azon résztvevők százalékos aránya, akiknél haspuffadás (hasfeszülés) jelentkezett

    hányás - azon résztvevők százalékos aránya, akiknél hányás jelentkezett

    fertőző hasmenés - fertőző hasmenésben szenvedő betegek százalékos aránya

    kórházi ápolás - hasmenés és/vagy intravénás rehidratálás miatt kórházi ápolásban részesülő személyek százalékos aránya

    AE - azon személyek százalékos aránya, akiknél nemkívánatos eseményt regisztráltak
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Randomization up to 2 weeks after the end of antibiotic therapy for all secondary endpoints.
    Minden másodlagos végpont esetében: randomizálástól kezdve az antibiotikum terápia befejezését követő max. 2 hétig
    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 Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned16
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Hungary
    Turkey
    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
    LVLS
    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 months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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: 660
    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: 185
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 475
    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 Yes
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children
    F.4 Planned number of subjects to be included
    F.4.1In the member state340
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 660
    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 Decision2020-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-01-11
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 27 21:27:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA