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    Summary
    EudraCT Number:2009-015728-27
    Sponsor's Protocol Code Number:AH-IBS-005
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-09
    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 ConcernedIreland - HPRA
    A.2EudraCT number2009-015728-27
    A.3Full title of the trial
    A Double Blind, Randomised, placebo-contoled Trial to establish teh safety and efficacy of a probiotic in subjects with Irritable Bowel Syndrome
    A.3.2Name or abbreviated title of the trial where available
    not available
    A.4.1Sponsor's protocol code numberAH-IBS-005
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot available
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlimentary Health Ltd
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAH1206
    D.3.2Product code AH1206
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    Oral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 type probiotic
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    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
    Irritable bowel Syndrome
    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 main efficacy variable will be;
    Responder Rates for adequate relief of abdominal pain/discomfortesponder
    Rates for adequate relief of IBS symptoms
    E.2.2Secondary objectives of the trial
    Global Improvement based on a 7 -point Likert scale performed on amonthly basis.
    Composite score
    Individual scores for the primary IBS symptoms;
    Bloating
    Diarrhoea
    Constipation
    An IBS -specific QOL and HADs score
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be female and between 18 and 65 years of age;

    2. Be able to give written informed consent;

    3. Be willing to comply with the study requirements;

    4. Be post-menopausal or, if of child-bearing potential, agree to use an adequate form of contraception (e.g., surgical sterilization, birth control pills, birth control implants, condoms AND spermicide, abstinence) as approved by the Investigator;

    5. Be willing to refrain from taking any dietary supplements or other foods that contain fermented live bacteria during the study;

    6. Be willing to refrain from taking any medications or preparations used in the therapy of IBS (herbal, dietary supplements, homeopathic preparations, etc.) during the study;

    7. If using fiber supplements (e.g., Trifyba, Fybogel, Konsyl, Isogel, Regulan, Ispagel, Celevac, Normacol), the dose and regimen have remained stable for at least 30 days and the subject will continue the same dose and regimen throughout the length of the trial.

    8. If using anti-depressants, the dose and regimen have remained stable for at least 90 days and the subject will continue the same dose and regimen throughout the length of the trial;

    9. If using products that contain nicotine or caffeine, agrees to continue current usage levels throughout the length of the trial;

    10. Have not participated in a clinical drug study or used an investigational new drug during the previous 30 days;

    11. Be in generally good health as determined by the Investigator, except for IBS symptoms;

    12. Have symptoms supportive of IBS: altered stool form, altered stool frequency, abnormal stool passage, passage of mucus, feeling of bloating or abdominal distension; and

    13. Satisfy the essential features of the Rome III diagnostic criteria for IBS which are:
    Recurrent abdominal pain or discomfort For at least 3 days/month in last 3 months associated with two or more of the following:
    a. Improvement with defecation,
    b. Onset associated with a change in frequency of stool,
    c. Onset associated with a change in form [appearance] of stool.
    E.4Principal exclusion criteria
    1. Are pregnant or nursing (lactating) females;

    2. Have IBS symptoms predominantly related to menstruation;

    3. Have alarm symptoms suggestive of an underlying organic disease (weight loss, nocturnal symptoms, blood in stools, family history of colorectal cancer, relevant abnormalities on physical examinations, short duration of symptoms, progressive deterioration of symptoms, abnormal laboratory test, positive stool cultures in subjects with diarrhoea-predominant IBS or abnormalities on colonoscopy/sigmoidoscopy or abdominal ultrasound which require further investigation);


    4. Have undergone prior gastrointestinal surgery (apart from appendectomy and hernia repair);


    5. Subjects over 55 years of age who have not had a sigmoidoscopy/colonoscopy performed in the previous 5 years;

    6. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, immunological, etc.) or condition (excluding IBS) which, in the Investigator’s judgment, contraindicates administration of the study medication or participation in the study;

    7. Have evidence of or history of t of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous five years;

    8. Use of anti-psychotics in the prior three months;

    9. Use of systemic steroids within the prior month;

    10. Have a condition, or are taking a medication, that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results;

    11. Have evidence of immunodeficiency;

    12. Major psychiatric disorder (DSM-III-R or DSM-IV), including major depression, psychoses, alcohol or substance abuse within the past 2 years;

    13. Subject is participating in a psychological IBS treatment approach that was initiated within the past 6 months (behavioural therapy, hypnosis, etc);

    14. Individuals who, in the opinion of the Investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial;

    15. Subjects who were previously screened for participation in this study and failed to meet entry criteria.

    16. Subjects who have had a previous cholescystectomy.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Variables
    The primary efficacy variables will be:

    • Responder Rates for adequate relief of abdominal pain/discomfort.
    • Responder Rates for adequate relief of IBS symptoms.
    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 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.8.3 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 Information not present in EudraCT
    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
    See protocol
    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.1.1.1In 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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-09-09. Yes
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    return to the use of pre-trial medication if in the investigators judgement is ok to recommence
    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 Decision2009-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-18
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