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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2015-000868-34
    Sponsor's Protocol Code Number:ZKES-EcNO-2015
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-04-09
    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 number2015-000868-34
    A.3Full title of the trial
    Randomized, placebo controlled phase III trial of a microbiological concomitant therapy/prevention of chemotherapeutical induced diarrhea (caused by inflammation and an impaired intestinal barrier) with E. coli Nissle 1917 (EcN)-Suspension in patients with gastric and colorectal cancer
    Randomisierte, Placebo-kontrollierte Studie der Phase III zur mikrobiologischen Begleittherapie/Prävention Chemotherapie-induzierter Diarrhöen (bedingt durch Inflammation und Darmbarrierestörung) mit E. coli Nissle 1917 (EcN)-Suspension bei Magen-und Colorectal-Tumorpatienten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study for investigating the effects of a probiotic on diarrhea caused by chemotherapy in patients with gastric, colon and rectum cancer
    Studie zur Untersuchung der Effekte eines Probiotikums auf Chemotherapie-induzierte Durchfälle bei Magen-, Dickdarm- und Enddarmkrebs-Patienten
    A.3.2Name or abbreviated title of the trial where available
    E. coli Nissle in oncology (EcNO-study)
    E. coli Nissle in der Onkologie (EcNO-Studie)
    A.4.1Sponsor's protocol code numberZKES-EcNO-2015
    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 SponsorZKES GmbH
    B.1.3.4CountryGermany
    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 supportZKES GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportARDEYPHARM GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZKES GmbH
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressWollgrasweg 49b
    B.5.3.2Town/ cityStuttgart
    B.5.3.3Post code70599
    B.5.3.4CountryGermany
    B.5.4Telephone number004971145924894
    B.5.5Fax number004971145924889
    B.5.6E-mailinfo@zkes-gmbh.de
    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 Mutaflor® Suspension
    D.2.1.1.2Name of the Marketing Authorisation holderArdeypharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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.3.9.3Other descriptive nameE. coli Nissle 1917 (concentration unit: cfu = colony forming units)
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10E08
    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 Yes
    D.3.11.13.1Other medicinal product typeprobiotic
    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
    Gastric or colorectal cancers, where a treatment with 5-Fluoruracil and one further chemotherapeutic remedy (either irinotecan or a platinum based chemotherapeutic remedy) is planned.
    Magen- und Colorectaltumoren, bei denen eine Behandlung mit 5-Fluoruracil sowie einem weiteren Chemotherapeutikum (entweder Irinotecan oder ein Platin basiertes Chemotherapeutikum) geplant ist.
    E.1.1.1Medical condition in easily understood language
    Gastric, colon or rectum cancer, where a chemotherapeutic Treatment with certain remedies is planned.
    Magen-, Dickdarm- oder Enddarmkrebs und eine geplante Chemotherapie mit bestimmten chemotherapeutischen Medikamenten.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    The study investigates whether a Escherichia coli Nissle-suspenison has a (preventive) antidiarrheal effect in patients with tumors who are treated with chemotherapeutic schemes which are associated with increased occurances of diarrhea. Diarrhea caused by treatment are thought to be reduced in intensity and/or frequency by the treatment with Escherichia coli Nissle-Suspension.
    In dieser Studie soll untersucht werden, ob Escherichia coli Nissle-Suspension eine (präventive) antidiarrhoische Wirkung bei Tumorpatienten besitzt, die mit Chemotherapie-Schemata behandelt werden, welche mit dem vermehrten Auftreten von Diarrhöen assoziiert sind. Therapieinduzierte Diarrhöen sollen durch die Behandlung mit Escherichia coli Nissle-Suspension in Intensität und/oder Frequenz gemindert werden.
    E.2.2Secondary objectives of the trial
    not applicable
    nicht zutreffend
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female adults; patients with gastric or colorectal cancer (stages III or IV), where a treatment with 5-Fluoruracil and one further chemotherapeutical remedy (either Irinoecan or a platinum based chemotherapeutical remedy) is planned, the addition of bevacizumab antibody is allowed as well; life expectancy of at least the trial duration; the first administering of the product under investigation must be able to take place 72 hours befor or after the beginning of the chemotherapeutical treatment, ideally at the same time; an inclusion into the study is only possible at the beginning of the first chemotherapeutic cycle; fertile female patients (aged 49 years or minor, the last menstruation occured in less than two years) have to be either surgically sterilized or use the same highly effective method of contraception for at least three minths; willingness to refrain from other probiotics or probiotic yoghurts, a systematic change of eating behavior should not be planned; sufficient knowledge of german language and sufficient psychological state for being able to answer questionnaires and assessment scales; informed written consent
    Männliche oder weibliche erwachsene Personen; Patienten mit Magen und Colorectaltumoren der Stadien III und IV, die mit dem Chemotherapeutikum 5-Fluoruracil sowie einem weiteren Chemotherapeutikum (Irinotecan oder ein Platin basiertes Chemotherapeutikum) behandelt werden, die Gabe von Bevacizumab-Antikörpern ist auch erlaubt; Voraussichtliche Lebenserwartung von mindestens der Studiendauer; Die erste Gabe der Studienmedikation muss +/- 72h bezogen auf Beginn der Chemotherapie erfolgen können, idealerweise sollten beiden Therapien gleichzeitig beginnen; Einschluss in die Studie erfolgt zeitgleich mit dem Beginn des ersten Chemotherapie-Zyklus, ein Einschluss zu einem späteren Zeitpunkt ist nicht möglich; Patientinnen im gebärfähigen Alter (49 Jahre oder jünger, die letzte Menstruation liegt weniger als zwei Jahre zurück) müssen entweder operativ sterilisiert sein oder seit mindestens drei Monaten die gleiche, hocheffektive Kontrazeptionsmethode nutzen; Bereitschaft des Patienten, während der Studiendauer weder andere Probiotika noch probiotisch angereicherte Jogurts einzunehmen. Eine systematische Ernährungsumstellung sollte nicht vorgesehen sein;
    Ausreichendes Verständnis der deutschen Sprache und ausreichender psychischer Zustand, um mit der Studie verbundene Informationen und Anweisungen zu verstehen und Fragebögen und Beurteilungsskalen ausfüllen zu können; Unterschriebene Einverständniserklärung
    E.4Principal exclusion criteria
    Participation in other clinical trials (currently or within the last 30 days); intolerance against ingredients of the product under investigation; pregnancy or lactation; beeing not able to consume the product under investigation orally; antidiarrheal therapy with antibiotics; alcohol or drug abuse within the last six months; any health condition (including abnormal blood parameters) which refuses a patient from taking part in the study according to the opinion of the investigator
    Teilnahme an einer anderen klinischen Studie (aktuell oder innerhalb der letzten 30 Tage); Unverträglichkeit gegenüber Inhaltsstoffen des Prüfpräparats; Schwangerschaft oder Stillzeit; Unfähigkeit, das Prüfpräparat oral aufzunehmen; antidiarrhoische Antibiotikatherapie; Alkohol- oder Drogenmissbrauch in den letzten sechs Monaten vor Studienbeginn oder andauernd; ein Gesundheitszustand (einschließlich abnormaler Laborwerte) der nach Ermessen des Prüfarztes eine Behandlung mit dem Prüfpräparat nicht zulässt
    E.5 End points
    E.5.1Primary end point(s)
    Common toxicity criteria (CTC) for diarrhea
    Common Toxicity Criteria (CTC) für Diarrhö
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the study (after six chemotherapeutic cycles)
    Ende der Studie (nach sechs Chemotherapiezyklen)
    E.5.2Secondary end point(s)
    Quality of life (according to SF12 and FACIT-D)
    stool consistency according to the Bristol stool scale
    anthropometry (Body Mass Index (BMI)
    bioelectrical impedance analysis (BIA)
    blood parameters (C-reactive protein, haematocrit)
    stool parameters (α1-Antitrypsin, Calprotectin)
    Lebensqualität nach SF12 und FACIT-D
    Stuhlkonsistenz gemäß Bristol-Skala
    Anthropometrie (Body Mass Index (BMI)
    Bioelektrische Impedanzanalyse (BIA))
    Laborparameter (C-reaktives Protein, Hämatokrit)
    Stuhlparameter (α1-Antitrypsin, Calprotectin)
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the study (after six chemotherapeutic cycles)
    Ende der Studie (nach sechs Chemotherapiezyklen)
    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 Yes
    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 concerned5
    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 years4
    E.8.9.1In the Member State concerned months6
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 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 state80
    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)
    Chemotherapy is continued as planned, according to the health estate of the patient. Diarrhea is treated according to a stepwise schema which is orientated at the grades of diarrhea. Mild diarrhea is treated with loperamide.
    Die Chemotherapie wird, wenn es der Gesundheitszustand zulässt, regulär weitergeführt. Die Diarrhöen werden gemäß eines Stufenschemas behandelt, das sich an der Schwere der Diarrhöen orientiert. Die erste Stufe stellt die Behandlung mit Loperamid dar.
    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 Decision2015-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-26
    P. End of Trial
    P.End of Trial StatusOngoing
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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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