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    Summary
    EudraCT Number:2011-002343-99
    Sponsor's Protocol Code Number:1.0
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-002343-99
    A.3Full title of the trial
    An Open-label Study into the Efficacy and Dosing of Probiotic Escherichia coli Nissle 1917 for Prevention of Gram-negative Gastric Colonisation in Ventilated Intensive Care Patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial in which intensive care patient on a ventilator will be given the probiotic E.coli Nissle in order to establish whether this organism can colonise the stomach.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and dosing of probiotic E.coli in gastric colonisation(V1.0)
    A.4.1Sponsor's protocol code number1.0
    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 SponsorHeart of England NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportArdeypharm
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHEFT
    B.5.2Functional name of contact pointResearch and Development Department
    B.5.6E-mailelizabeth.adey@heartofengland.nhs.uk
    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
    D.2.1.1.2Name of the Marketing Authorisation holderPharma-Zentrale 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 Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEscherichia coli Nissle 1917 suspension
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasogastric use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEscherichia coli Nissle 1917
    D.3.9.4EV Substance CodeAS1
    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 number10^8
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gastric colonisation by pathogenic gram negative bacteria in ventilated adult ICU patients and it's prevention by the probiotic E.coli Nissle 1917
    E.1.1.1Medical condition in easily understood language
    Can administration of the probiotic E.coli Nissle 1917 prevent harmful bacteria from colonising the stomach of adult intensive care patients who are on breathing machines.
    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 determine if the probiotic E.coli Nissle will colonise the stomach of ventilated (on a breathing machine)intensive care patients after it is administered directly into the stomach via a nasogastric tube (tube going from nose into stomach).
    E.2.2Secondary objectives of the trial
    1.To determine the optimum dose of E.coli Nissle that needs to be administered in order to achieve this. 2.To determine the time to gastric colonisation(if successful). 3.To determine if there is a difference in the colonisation rates with potentially harmful bacteria between patients who receive E.coli Nissle and those who don't.. 4.To determine if there is a difference in the rates of ventilator-associated pneumonia between patients who receive E.coli Nissle and those who don't.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    We will recruit a total of 60 patients from the Heart of England NHS Foundation Trust critical care units, using a non-treatment group as the control. Patients ≥18 years that have been intubated for ≤24 hours and who are expected to require mechanical ventilation with a tracheal tube or tracheostomy for ≥48 hours will be considered for enrolment.
    E.4Principal exclusion criteria
    The following exclusion criteria will apply: 1. Imminent treatment withdrawal 2. Designated consultee does not provide assent 3. Pregnancy or lactation 4. Therapy with immunosuppressants 5. Absolute neutrophil count ≤500/mm3 6. Gastrointestinal bleeding 7. Prosthetic cardiac valve or vascular graft 8. Cardiac trauma 9. History of rheumatic fever, endocarditis or congenital heart disease 10.Contraindication to enteral feeding 11.Gastro-oesophageal or intestinal injury or foregut surgery during the current admission 12.Acute pancreatitis 13.Participation in a CTIMP within the last 30 days
    E.5 End points
    E.5.1Primary end point(s)
    This is a proof of principle study. The primary outcome will be demonstration of successful gastric colonisation by E.coli Nissle in ventilated ICU patients.
    E.5.2Secondary end point(s)
    1. Incidence of gastric and oropharyngeal colonisation by opportunistic pathogenic GNB after administration of probiotic. 2. Time of the first gastric colonisation by opportunistic pathogenic Gram-negative bacteria. 3. Time of the first tracheal colonisation by opportunistic pathogenic Gram-negative bacteria 4. Cumulative incidence of ICU-acquired infection 5. Number of ventilator free days up to day 28 after randomisation 6. Number of antibiotic free days up to day 28 after randomisation 7. ICU length of stay 8. Hospital length of stay 9. ICU mortality 10.Hospital mortality 11.28 & 90-day mortality
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data will be collected during the time the patient remains on a ventilator. The overall end point for each patient will be 90 day mortality or the time to hospital discharge if this is later.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    2 different doses of E.coli Nissle compared to standard treatment
    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
    The trial will end at 90 days after enrolment of the last subject or at time of hospital discharge if this is later.
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    Not applicable
    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 Decision2011-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-13
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