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    Summary
    EudraCT Number:2011-006269-17
    Sponsor's Protocol Code Number:SPON1069-11
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-09-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-006269-17
    A.3Full title of the trial
    A double blind placebo controlled randomised clinical trial to study the effect of Probiotics for the prevetion or amelioration of Antibiotic Associated Diarrhoea in residents of care homes in South Wales and England
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    THE PROBIOTICS FOR ANTIBIOTIC ASSOCIATED DIARRHOEA (PAAD) STUDY
    Stage II : A double blind randomised placebo controlled trial to determine the effect of probiotics on antibiotic associated diarrhoea in care home residents.
    A.3.2Name or abbreviated title of the trial where available
    Probiotics for Antibiotic Associated Diarrhoea, (PAAD), a randomised controlled trial
    A.4.1Sponsor's protocol code numberSPON1069-11
    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 SponsorCardiff University, Research & Development Commercial Department
    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 supportHealth Technology Assessment (HTA)
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportActial Farmaceutica LDA
    B.4.2CountryPortugal
    B.4.1Name of organisation providing support
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSouth East Wales Trials Unit (SEWTU), Cardiff University
    B.5.2Functional name of contact pointJulia Townson
    B.5.3 Address:
    B.5.3.1Street Address7th Floor, Neuadd Meirionnydd, Heath Park
    B.5.3.2Town/ cityHeath Park, Cardiff
    B.5.3.3Post codeCF14 4YS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02920687606
    B.5.5Fax number02920687612
    B.5.6E-mailtownson@cf.ac.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 No
    D.2.1.1.1Trade name VSL#3
    D.2.1.1.2Name of the Marketing Authorisation holderS.I.I.T srl, Via Ariosto - 50/60, 20090 Trezzano sul, Naviglio, (MI), Italy
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameVSL#3®
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Powder for 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.3.8INN - Proposed INNVSL#3®
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeSPON1069-11
    D.3.9.3Other descriptive nameNutritional supplement
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.4
    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.3.11.13.1Other medicinal product typeFreeze dried species of live lactic acid bacteria and bifido bacteria
    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 placeboPowder for oral 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
    Antibiotic Associated Diarrhoea
    E.1.1.1Medical condition in easily understood language
    Diarrhoea which occurs while taking an antibiotic
    E.1.1.2Therapeutic area Body processes [G] - Microbiological Phenomena [G06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10055956
    E.1.2Term Antibiotic-associated diarrhoea
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of probiotics vs placebo, taken in conjunction with antibiotics, on the incidence of (AAD) in care home service users
    E.2.2Secondary objectives of the trial
    •To compare the effectiveness of probiotics vs. placebo, taken in conjunction with antibiotics, on the duration and severity of AAD in care home SUs.
    •To compare the effectiveness of the probiotics vs. placebo in reducing the incidence of C. difficile–associated diarrhoea (CDAD) in care home SUs.
    •To evaluate the impact of probiotics on Quality of Life (QoL) in care home SUs.
    •To evaluate the cost effectiveness of probiotics for AAD in care home SUs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    INCLUSION CRITERIA
    •Resident in a care home for 24 hours or more, with a minimum planned residential care of 1 month.
    •Able to provide informed consent or have a personal legal representative who can provide consent for inclusion.
    •If the SU takes a regular probiotic but chooses to discontinue the probiotic
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA
    •Severely immuno-compromised, e.g. known severe neutropenia
    •Has artificial heart valve in situ.
    •Medical history of acute pancreatitis.
    •Requires naso-jejunal feeding /nasogastric feeding due to difficulty of administering probiotic.
    •Currently has a colostomy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the occurrence of at least one episode of AAD during the eight weeks following randomisation. AAD is defined as three or more loose stools (defined as a 5 – 7 on the British Stool Chart) in a 24 hour period following a period of normal stool consistency.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between randomisation and during eight weeks following randomisation
    E.5.2Secondary end point(s)
    • Proportion of stool samples positive for Clostridium difficile toxin A or B from SUs who develop AAD during the eight week follow-up period.
    • Duration, frequency and recurrence of AAD during the eight-week follow-up period.
    • QoL, measured using EQ-5D at the point of consent, at the time of randomisation and each week during the eight-week follow-up period.
    • Recovery from illness that triggered antibiotic treatment.
    • Healthcare Resource UseHealth care utilisation costs, including GP and practice nurse consultations, other medication, procedures, investigations, hospital appointments, A&E attendances and any hospital inpatient admissions, measured at the end of the eight-week follow-up period.
    • Unplanned hospitalisations, including all-cause and AAD related, during the eight-week follow-up period.
    • Adverse Events: e.g. vomiting, abdominal pain, excessive flatulence, bloating, skin rashes, during the eight-week follow-up period.
    • Adherence to the antibiotic, probiotic/placebo treatment course.
    • All causes of mortality in the 8 week follow up period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between randomisation and during eight weeks folowing randomisation
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Health Economics
    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 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 concerned24
    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
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Service Users resident in care homes with reduced mental capacity.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    All service users resident in care homes will return to the normal practices of the care home
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation South East Wales Trial Unit
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-10-31
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