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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   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).

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    Summary
    EudraCT Number:2016-001850-16
    Sponsor's Protocol Code Number:2016-001850-16
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-24
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-001850-16
    A.3Full title of the trial
    Studies of interplays between insulin resistance associated with immunosuppression and the gut and saliva microbiota composition of young, healthy men
    Undersøgelse af sammenspillet mellem insulinresistens associeret med immunsuppression og tarm- og spyt mikrobiota hos unge, raske mænd
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of glucocorticoids on human gut bacteria
    Effekten af glykokortikoid på tarmens bakteriesammensætning
    A.3.2Name or abbreviated title of the trial where available
    GEMP
    GEMP
    A.4.1Sponsor's protocol code number2016-001850-16
    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 Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, Section of Metabolic Genetic
    B.1.3.4CountryDenmark
    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 supportUniversity of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, section of Metabolic Genetic
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, Section of Metabolic Genetic
    B.5.2Functional name of contact pointOluf Borbye Pedersen
    B.5.3 Address:
    B.5.3.1Street AddressUniveristetsparken 1, 1st floor
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.6E-mailoluf@sund.ku.dk
    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 Prednisolon "DLF"
    D.2.1.1.2Name of the Marketing Authorisation holderDansk Lægemiddelforsyning DLF
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 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 INNPrednisolone
    D.3.9.3Other descriptive namePREDNISOLONE
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 25
    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.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 Depo-Medrol
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer ApS
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethylprednisolone acetate
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE ACETATE
    D.3.9.4EV Substance CodeSUB03255MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Young healthy men
    Unge raske mænd
    E.1.1.1Medical condition in easily understood language
    Young healthy men
    Unge raske mænd
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10062026
    E.1.2Term Investigation
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Examine structural changes in gut microbiota before, during and after glucocorticoid treatmet.
    Undersøge strukturelle ændringer i tarmmikrobiomet før, under og efter glukokortikoidbehandling.
    E.2.2Secondary objectives of the trial
    Investigate changes in metabolic markers in urine, saliva, blood, serum and fecal samples following glucocorticoid treatment.
    Undersøge ændringen i forskellige biologiske markører målt i urin, spyt, blod, serum og afføring efter glukokortikoidbehandling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male
    - Age 18-35 years, both inclusive
    - 18.5 kg/m2 < Body Mass Index (BMI) < 27.0 kg/m2
    - Weight stable, defined by no history of loss or gain of more than 3kg, two months prior to
    recruitment
    - Normal glucose metabolism evaluated at the time of screening by Glycosylated Hemoglobin, Type A1c (HbA1c) < 39mmol/mol
    - Normal kidney functions as evaluated by normal plasma creatinine levels adjusted for age
    - Normal liver function as evaluated by plasma Alanine Amino Transferase (ALAT) 10-70 IU/L
    - Normal blood pressure measured with a calibrated automated sphygmomanometer. Systolic pressure < 140mmHg and diastolic pressure < 90mmHg
    - Mand
    - Alder mellem 18-35, begge inklusive
    - BMI mellem 18,5 og 27 kg/m2
    - Vægtstabil, defineret ved ikke at have haft et vægttab eller en vægtøgning på mere end 3kg, indenfor de sidste 3 måneder af screeningsdagen.
    - Normalt blodsukker, bedømt ud fra den gennemsnitlige blodsukkerkoncentration målt ved HbA1c der skal være mindre end 39mmol/mol
    - Normal nyrefunktion, bedømt ud fra nyretallet kreatinin, justeret for alder.
    - Normal leverfunktion, bedømt ud fra leverenzymet ALAT der skal være mellem 10 og 70 IU/L.
    - Normalt blodtryk. Systolisk blodtryk under 140mmHg og diastolisk blodtryk under 90mmHg.
    E.4Principal exclusion criteria
    - Smoking on daily basis
    - Oral intake of any form of prescribed medication four months prior to recruitment
    - Daily use of probiotics four months prior to recruitment
    - Deliberate changes in diet two months prior to recruitment
    - Chronic or acute (the latter within the recent two months) illness of any type
    - Previous gastrointestinal operation, disregarding uncomplicated appendicitis
    - Previous mental disorders
    - Unable to give informed consent
    - Need of medical treatment during the study
    - Rygning på daglig basis
    - Brug af lægeordineret medicin indenfor de sidste 4 måneder af screeningsdagen.
    - Daglig brug af probiotika.
    - Bevidste ændringer i kost eller motionsvaner indenfor de sidste 2 måneder af screeningsdagen.
    - Kronisk eller akut (akut: indenfor de sidste 2 måneder af screeningsdagen) sygdom.
    - Tidligere operation i maveregionen, fraset ukompliceret blindtarmsbetændelse.
    - Tidligere mentale lidelser.
    - Ikke i stand til at give informeret samtykke.
    - Behov for medicinsk behandling i løbet af forsøget.
    E.5 End points
    E.5.1Primary end point(s)
    Structural change of gut microbiota during and after glucocorticoid treatment.
    Strukturelle ændringer i tarmmikrobiomet under og efter glukokortikoidbehandling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Spring 2017
    Forår 2017
    E.5.2Secondary end point(s)
    Changes in metabolic markers in urine, saliva, blood, serum and fecal samples during and after glucocorticoid treatment.
    Ændringer i forskellige biologiske markører målt i urin, spyt, blod,serum og afføring under og efter glukokortikoidbehandling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Fall 2017
    Efterår 2017
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Implications of glucocorticoid treatment on human gut microbiota and related physiological changes.
    Følger af glukokortikoidbehandling i det humane tarmmikrobiom og relaterede fysiologiske ændringer.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Clinical trial investigating the effect of glucocorticoids on the gut microbiota
    Klinisk forsøg der undersøger effekten af glukokortikoider på tarmens mikrobiota
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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
    Ingen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-08
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    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
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