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    Summary
    EudraCT Number:2017-004248-39
    Sponsor's Protocol Code Number:PPI-microbiome
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-05
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-004248-39
    A.3Full title of the trial
    Effect of Proton Pump Inhibitors on the duodenal microbiome in healthy volunteers
    Effect van Proton Pomp Inhibitoren op het duodenale microbioom in gezonde vrijwilligers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of acid suppressive therapy on the bacteria in the small bowel
    Effect van zuurremmers op de bacteriën in de dunne darm
    A.3.2Name or abbreviated title of the trial where available
    PPI and duodenal microbiome
    PPI en duodenaal microbioom
    A.4.1Sponsor's protocol code numberPPI-microbiome
    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 SponsorTARGID, KU Leuven
    B.1.3.4CountryBelgium
    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 supportTARGID, KU Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTARGID, KU Leuven
    B.5.2Functional name of contact pointTARGID
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49- box 701
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3216372093
    B.5.5Fax number+3216344318
    B.5.6E-maillucas.wauters@kuleuven.be
    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 Pantomed 40mg
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Belgium
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 namePantomed 40mg
    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 INNPANTOPRAZOLE
    D.3.9.1CAS number 102625-70-7
    D.3.9.3Other descriptive namePANTOPRAZOLE
    D.3.9.4EV Substance CodeSUB09608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.13.1Other medicinal product typepharmaceutical agent
    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 will assess the effect of Proton Pump Inhibitors (PPI) on the duodenal, oral and fecal microbiota composition in healthy volunteers
    We bestuderen het effect van proton pomp inhibitoren (PPI) op het duodenale, orale en fecale microbioom in gezonde vrijwilligers
    E.1.1.1Medical condition in easily understood language
    We will assess the effect of acid suppression on the bacteria of the small bowel, oral cavity and feces in healthy volunteers
    We bestuderen het effect van zuurremmers op de bacteriën van de dunne darm, de mondholte en de stoelgang in gezonde vrijwilligers
    E.1.1.2Therapeutic area Body processes [G] - Microbiological Phenomena [G06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of Proton Pump Inhibitors (PPI) on the duodenal, oral and fecal microbiota composition in healthy volunteers
    Om het effect van proton pomp inhibitoren (PPI) op het duodenale, orale en fecale microbioom te bestuderen in gezonde vrijwilligers
    E.2.2Secondary objectives of the trial
    Correlate changes in the microbiota with bile acids, intestinal permeability and histology, salivary cortisol levels and blood hs-CRP.
    Correleren van veranderingen in microbioom met galzouten, intestinale permeabiliteit en histologie, cortisol in speeksel en hs-CRP in bloed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects aged between 18 and 64 years inclusive
    - Male or female (not pregnant or lactating and using contraception or postmenopausal)
    - Normal bowel habits (defecation once every 3 days up to 3 times a day)
    - Witnessed written informed consent
    - Access to home freezer (-18 to -20°C)
    - Capable to understand and comply with the study requirements
    -18 tot en met 64 jaar
    -man en vrouw (niet zwanger, geen borstvoeding en gebruik van contraceptie of postmenopauzaal)
    - Normale stoelgangsfrequentie (minimaal 1x om de 3 dagen, maximaal 3x per dag)
    - Toegang tot een diepvries thuis (minimaal -18°C) voor bewaring van de stalen
    -Ondertekend toestemmingsformulier
    - In staat om de studie vereisten te begrijpen en na te leven
    E.4Principal exclusion criteria
    - Active gastrointestinal or psychiatric symptoms (stable dose of single antidepressant allowed)
    - Use of acid suppressive drugs, immunosuppressants or antibiotics within 3 months before sampling
    - Use of drugs influencing gut motility or stool consistency, NSAIDs, anti-allergy drugs, bile acid sequestrants or ursodeoxycholic acid within 2 weeks before sampling
    - History of major abdominal surgery, including cholecystectomy but not appendectomy
    - Personal or family (first-degree relative) history of diabetes mellitus type 1, celiac disease, inflammatory bowel disease, psoriasis, rheumatic or other auto-immune diseases (including therapy)
    - Allergy or atopy (eczema, asthma and/or allergic rhinoconjunctivitis) (including therapy)
    - Kidney, liver or coagulation disorders
    - Active coronary or peripheral artery disease
    - Diabetes mellitus type 2 (including therapy)
    - Active malignancy (including therapy)
    - Known HIV, HBV or HCV infection (including therapy)
    - Magnetizable objects (e.g. cochlear implants, neural stimulator, pacemaker, metal fragments or implants) or claustrophobia (MRI safety criteria, other procedures can still take place)
    - Significant alcohol use (>10 units/weeks)
    - Any use of alcohol or smoking in the 2 days before sampling
    - Females who are pregnant or lactating, who are not using contraception and premenopausal
    - Allergy or intolerance to PPI
    - Actieve gastrointestinale of psychiatrische symptomen (stabiele dosis van 1 antidepressivum toegelaten)
    - Inname van zuurremmers, medicatie die het afweersysteem onderdrukken of antibiotica minder dan 3 maanden voor staalname
    - Inname van medicatie die de darmwerking of stoelgangsconsistentie beïnvloedt, ontstekingsremmers, anti-allergie medicatie, anionen-uitwisselaars (Questran® of Colestid ®) of ursodeoxycholzuur (Ursofalk® of Ursochol®) minder dan 2 weken voor staalname
    - Patiënten met in het verleden een grote maag- of darmoperatie, inclusief verwijdering van de galblaas maar niet de appendix of blinde darm
    - Persoonlijke of familiale (eerstegraads familielid) voorgeschiedenis van diabetes mellitus type 1 (= auto-immuun gemedieerde vorm van suikerziekte), coeliakie (= glutenallergie), inflammatoir darmlijden, psoriasis, reumatische of auto-immuunaandoeningen
    - Patiënten met allergie of atopie (eczeem, astma, allergische rhinoconjunctivitis) of behandeling hiervoor
    - Patiënten met nier-, lever- of stollingsproblemen
    - Patiënten met actief coronair of perifeer vaatlijden
    - Patiënten met type 2 diabetes mellitus of behandeling hiervoor
    - Patiënten met actieve maligniteit of behandeling hiervoor
    - Patiënten met gekende HIV, hepatitis B of C infectie of behandeling hiervoor
    - Patiënten met magnetiseerbare metalen voorwerpen in hun lichaam (bv. hoorimplantaat, metalen fragmenten of prothesen, pacemaker of neurostimulator) of claustrofobie (enkel voor MRI, andere procedures kunnen doorgaan)
    - Overmatig alcoholgebruik (>10 eenheden/week)
    - Gebruik van alcohol of roken in de 2 dagen voor staalname
    - Vrouwen die zwanger zijn, borstvoeding geven of geen contraceptie gebruiken en premenopauzaal zijn
    - Allergie of intolerantie voor PPI
    E.5 End points
    E.5.1Primary end point(s)
    Microbiota composition of the duodenum, feces and saliva
    Bacteriële samenstelling van het duodenum, stoelgang en speeksel
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study inclusion, after baseline period of 4 weeks and after treatment with Pantomed 40mg once daily for 4 weeks
    Bij inclusie in de studie, bij vervroegde controle na 4 weken en na behandeling met Pantomed 40mg éénmaal daags gedurende 4 weken
    E.5.2Secondary end point(s)
    Bile acids, intestinal permeability, mucosal inflammation, salivary cortisol and blood hs-CRP
    Galzouten, intestinale permeabiliteit, mucosale inflammatie, cortisol in speeksel en hs-CRP in bloed
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study inclusion, after baseline period of 4 weeks and after treatment with Pantomed 40mg once daily for 4 weeks
    Bij inclusie in de studie, bij vervroegde controle na 4 weken en na behandeling met Pantomed 40mg éénmaal daags gedurende 4 weken
    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
    To assess alterations of the duodenal, oral and fecal microbiota composition with PPI
    Om veranderingen in de duodenale, orale en fecale bacteriële samenstelling met PPI te bestuderen
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 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.8.5The 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 years2
    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 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: 40
    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 state40
    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)
    NA
    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 Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-22
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