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    The EU Clinical Trials Register currently displays   41231   clinical trials with a EudraCT protocol, of which   6758   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2016-002550-20
    Sponsor's Protocol Code Number:AMIRA
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Suspended by CA
    Date on which this record was first entered in the EudraCT database:2016-09-30
    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 number2016-002550-20
    A.3Full title of the trial
    Allogeneic microbiota-reconstitution (AMR) for the Treatment of patients with diarrhea-predominant irritable bowel Syndrome (IBS-D) - the AMIRA trial
    Placebo-kontrollierte, oligozentrische Studie zur allogenen Mikrobiom-Rekonstitution (AMR) als neuem Therapieansatz in der Behandlung von Patienten mit Reizdarmsyndrom vom Diarrhoe-dominanten Typ
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fecal bacteriotherapy for patients with diarrrhea-dominant irritable bowel syndrome
    Stuhltransplantation bei Reizdarmpatienten vom Durchfall-Typ
    A.3.2Name or abbreviated title of the trial where available
    AMIRA-trial
    AMIRA-Studie
    A.4.1Sponsor's protocol code numberAMIRA
    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 Ulm
    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 supportDeutsche Forschungsgesellschaft
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Ulm
    B.5.2Functional name of contact pointDepartment of Internal Medicine I
    B.5.3 Address:
    B.5.3.1Street AddressAlbert-Einstein-Allee 23
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89081
    B.5.3.4CountryGermany
    B.5.4Telephone number+49731500-44501
    B.5.5Fax number+49731500-44502
    B.5.6E-mailthomas.seufferlein@uniklinik-ulm.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 No
    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 nameStool suspension
    D.3.4Pharmaceutical form Oral/rectal suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraduodenal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNreconstituted stool suspension
    D.3.9.2Current sponsor codeAMIRA
    D.3.10 Strength
    D.3.10.1Concentration unit billion CFU billion colony forming units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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 placeboSuspension for injection in pre-filled syringe
    D.8.4Route of administration of the placeboIntraduodenal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    diarrhea-predominant irritable bowel syndrome
    Reizdarmsyndrom vom Diarrhoe-dominanten Typ
    E.1.1.1Medical condition in easily understood language
    diarrhoe-predominant irritable bowel syndrome
    Reizdarmsyndrom vom Durchfalltyp
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    Improvement of symptom severity of IBS-patients
    Symptomverbesserung bei Reizdarmpatienten
    E.2.2Secondary objectives of the trial
    safety
    Quality of Life
    changes of microbiom
    Sicherheitsaspekte
    Lebensqualität
    Veränderungen des Mikrobioms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    age 18-70 years old
    written informed consent
    Irritable bowel Syndrome of diarrhea-predominant type according to ROME III criteria
    duration of symptoms > 1 year before study inclusion
    persistent symptoms for > 1 year before study inclusion
    relevant ailments or symptoms resulting in the reduction in the quality of life according to the IBS-QOL Questionnairs (Score < 60 Points) in the last 6 months before study inclusion
    no specific findings in gastroscopy and colonoscopy in the last 2 years
    Alter 18-70 Jahre
    unterschriebene Einwilligung
    Reizdarmsyndrom vom Diarrhoe-dominanten Typ entsprechend der ROME III Kriterien
    Dauer der Symptome > 1 Jahr vor Studieneinschluss
    Anhaltende Beschwerden > 1 Jahr vor Studieneinschluss
    Relevante Beschwerden und Symptome entsprechend einer reduzierten Lebensqualität nach den IBS-QOL Fragebogen (Score < 60 Punkte) in den letzten 6 Monaten vor Studieneinschluss
    keine Auffälligkeiten in einer Gastroskopie/Koloskopie in den letzten 2 Jahren
    E.4Principal exclusion criteria
    chronic inflammatory diseases
    gastrointestinal infectious diseases
    microscopic colitis
    celiac disease
    Diarrhoea due to suspected fructose or lactose intolerance
    Presence of gastrointestinal malignancy or intestinal polyps
    irritable bowel Syndrome of other type then IBS-D
    Presence of Bile acid diarrhoea (BAD)
    constipation
    Abdominal ailment or symptom caused by conditions other then IBS-D
    dementia
    Recent abdominal operations
    antibiotic therapy in the last 3 months
    pregnancy
    Unwillingness to use proven highly effective contraceptive methods by a woman with child-bearing potential for the duration of the study
    Concurrent participation in another clinical study
    Inability to provide informed consent
    chronisch-entzündliche Darmerkrankungen
    infektiöse Darmerkrankungen
    kollagenen/lymphozytären colitis
    Sprue
    Durchfälle, die durch das Vorliegen einer Fructose- oder Lactoseintoleranz verursacht sind
    Voliegen eines gastrointestinalen Malignoms oder intestinaler Polypen
    Reizdarmsyndrom eines anderen Typs außer IBS-D
    Vorliegen von chologenen Diarrhoen
    Obstipation
    Beschwerden oder Symptome durch andere Erkrankungen als IBS-D
    Demenz
    Kürzlich zurück liegende Operation im Bereich des Abdomens
    Antibiotika-Einnahme in den letzten 3 Monaten
    Schwangerschaft
    Fehlende Bereitschaft gebärfähiger Frauen für die Dauer der Studienteilnahme eine hocheffektiven Kontrazeptionsmethode anzuwenden
    Gleichzeitige Teilnahme an einer anderen Studie
    Sprachliche Barriere bei Einwilligung
    E.5 End points
    E.5.1Primary end point(s)
    Significant decrease of IBS-SSS
    Abfall des IBS-SSS
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months after intervention
    3 Monate nach Intervention
    E.5.2Secondary end point(s)
    Improvement of IBS-QOL
    Safety aspects
    changes and acceptance of donor microbiome
    Verbesserung des IBS-QOL
    Sicherheitsaspekte
    Veränderungen des Mikrobioms des Empfängers und Akzeptanz des Spendermikrobioms
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year after intervention
    1 Jahr nach Intervention
    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 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 concerned2
    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 Yes
    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
    end of study: one year after the last intervention
    geplantes Studienende: 1 Jahr nach der letzten Intervention
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state42
    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)
    standard therapy
    Standardtherapie
    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 Decision2017-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-22
    P. End of Trial
    P.End of Trial StatusSuspended by CA
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