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   43873   clinical trials with a EudraCT protocol, of which   7292   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:2016-003654-33
    Sponsor's Protocol Code Number:FLORAL-Sb185
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-27
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-003654-33
    A.3Full title of the trial
    Effects of the probiotic Saccharomyces boulardii CNCM I-745 and the antibiotic Amoxicillin on the gut microbiota of healthy volunteers
    An open-label, randomized, parallel groups, monocentric study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of the probiotic Saccharomyces boulardii CNCM I-745 and the antibiotic Amoxicillin on the gut microbiota of healthy volunteers
    An open-label, randomized, parallel groups, monocentric study
    A.3.2Name or abbreviated title of the trial where available
    Effects of Saccharomyces b. and Amoxicillin on the gut microbiota
    A.4.1Sponsor's protocol code numberFLORAL-Sb185
    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 SponsorBIOCODEX
    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 supportBIOCODEX
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTC North GmbH & Co.KG
    B.5.2Functional name of contact pointAnke Heiermann
    B.5.3 Address:
    B.5.3.1Street AddressMartinistraße 64
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20251
    B.5.3.4CountryGermany
    B.5.4Telephone number004940524719212
    B.5.5Fax number004940524719129
    B.5.6E-maila.heiermann@ctc-north.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 Yes
    D.2.1.1.1Trade name Ultra-Levure®
    D.2.1.1.2Name of the Marketing Authorisation holderBiocodex
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameUltra-Levure®
    D.3.4Pharmaceutical form Capsule
    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 INNSaccharomyces boulardii
    D.3.9.2Current sponsor codeCNCM I-745
    D.3.9.3Other descriptive nameSACCHAROMYCES BOULARDII
    D.3.9.4EV Substance CodeSUB15171MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Clamoxyl®
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameClamoxyl
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNAmoxycillin
    D.3.9.1CAS number 26787-78-0
    D.3.9.2Current sponsor codeAmoxycillin
    D.3.9.3Other descriptive nameAMOXYCILLIN TRIHYDRATE - EP
    D.3.9.4EV Substance CodeSUB56828
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 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
    Healthy volunteers
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall goals of this study are to characterize the changes in the human microbiota that result from the ingestion of the antibiotic Amoxicillin and to evaluate the ability of S. boulardii CNCM I-745 to prevent, diminish or shorten these changes.

    The primary objective is to assess the preventive effects of S. boulardii CNCM I-745 on the gut microbiota changes induced by Amoxicillin in the healthy volunteers.
    E.2.2Secondary objectives of the trial
    The secondary objective is to describe the clinical characteristics of the subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects enrolled in the study will have to fulfill the following criteria:
    1) Healthy volunteers aging from 18 to 65 years (male or female)
    2) Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests and electrocardiogram (ECG)
    3) With a body mass index (BMI) comprised between 18.5 and 30.0 kg/m2 and weight >50 kg at Screening
    4) Able to comply with study requirements and to provide signed informed consent
    5) No clinically relevant abnormalities in results of laboratory tests as per Investigator’s judgement
    6) For women of childbearing potential
    o A negative urine pregnancy test immediately prior to starting the study treatment
    o Agreement to comply with approved methods of contraception during the whole study): unless they meet the criteria of post-menopausal, i.e. 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, should use one or more of the following acceptable methods of contraception that should be maintained throughout the study:
    ~ Surgical sterilization
    ~ Hormonal contraception (implantable, patch, oral, intra-muscular)
    ~ Intra-uterine device
    ~ Double barrier method (diaphragm plus condom)
    ~ At the discretion of the investigator, total abstinence is acceptable in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance
    E.4Principal exclusion criteria
    Subjects presenting with one of the following criteria will not be enrolled in this study:
    1) History of hypersensitivity to Saccharomyces boulardii, brewer’s or baker’s yeast, amoxicillin or any other penicillin
    2) History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam)
    3) Hypersensitivity to the active substance, to one of the ingredients, to any of the penicillins or to any of the excipients of the study drugs
    4) Contraindication and special warning to the study drugs according to the SmPCs
    5) History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average
    6) History of chronic or recurrent diarrhea with spontaneous unformed bowel movements equivalent to or more often than 3 times daily
    7) Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy performed at least more than one year ago)
    8) History of Clostridium difficile infection
    9) Known chronic or recurrent systemic disorder that may interfere with the study drug evaluation
    10) Associated immune deficiency
    11) Severe hepatic or renal impairment
    12) Active gastrointestinal disease
    13) Patients with a central venous catheter
    14) Oral or systemic antibacterial therapy during the 3 months prior to study enrollment
    15) New prescription medications during the 2 weeks prior to study enrollment
    16) Use of any drug that alters gut microbiota or function, such as laxatives, antiemetics, cisapride, antisecretory or adsorbent treatments (racecadotril, smectite, activated charcoal), opiates such as loperamide, atropine and other cholinergic agents, during 4 weeks prior to study enrollment
    17) Intake of antifungals within 14 days prior to study enrollment
    18) Substantial changes in eating habits within 30 days prior to receiving the first dose of IMP product, as assessed by the Investigator
    19) Patients enrolled in another clinical trial within the past 30 days
    20) Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.
    21) Current smoker
    22) Breast-feeding woman.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the change in the gut microbiota, using species richness, species diversity, PCA, and individual Operational Taxonomic Units (OTUs) frequencies.
    Thus, communities will be described using species richness, species diversity, Principal Coordinate Analysis (PCA), and individual OTU frequencies. ANOVA and discriminant analyses will differentiate the microbiota according to the presence or absence of treatments. The frequencies of OTUs in this analysis will serve to indicate the resilience of microbial communities to antibiotic treatment, and the ability of probiotics to preserve or restore OTU frequencies to approximate those of the normal gut microbiota.
    E.5.1.1Timepoint(s) of evaluation of this end point
    (-21 to -7 days), Day 0, Day3, Day 7, Day 10, Day 14, Day 21
    E.5.2Secondary end point(s)
    The following population characteristics: physical examination, ECG, vital signs, safety blood and urinary laboratory tests, serology, alcohol breath test, drug screen
    E.5.2.1Timepoint(s) of evaluation of this end point
    The population characteristics will be described for all of the parameters collected at the screening
    The comparability of the treatment groups at baseline will be evaluated.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Controllgroup without any medication
    E.8.2.4Number of treatment arms in the trial4
    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
    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 months6
    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 No
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 48
    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 Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    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 Decision2016-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-17
    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-Tue May 07 06:48:58 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA