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    Summary
    EudraCT Number:2017-005111-14
    Sponsor's Protocol Code Number:HPE-4/LCR
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-09
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-005111-14
    A.3Full title of the trial
    First-line Treatment of Helicobacter pylori with the Probiotic Lactobacillus casei rhamnosus LCR35 Alone or in Combination with a Levofloxacin-based Sequential Therapy: A Randomized, Placebo-controlled Phase 3 Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Helicobacter pylori eradication with Probiotic Lactobacillus casei rhamnosus LCR35 Alone or in Combination with Antibiotic Therapy
    A.3.2Name or abbreviated title of the trial where available
    FORECAST
    A.4.1Sponsor's protocol code numberHPE-4/LCR
    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 SponsorKepler Universitätsklinikum, Medcampus III, Klinik für Interne 2
    B.1.3.4CountryAustria
    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 supportGebro Pharma GmbH
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportSandoz GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportG.L. Pharma
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMag. Andreas Raffeiner GMBH
    B.5.2Functional name of contact pointAndreas Raffeiner
    B.5.3 Address:
    B.5.3.1Street AddressReiterstrasse9
    B.5.3.2Town/ cityWalding
    B.5.3.3Post code4111
    B.5.3.4CountryAustria
    B.5.4Telephone number+43723483764
    B.5.5Fax number+43723485420
    B.5.6E-mailoffice@studien-monitor.at
    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 Antibiophilus
    D.2.1.1.2Name of the Marketing Authorisation holderBiose Industrie
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameAntibiophilus
    D.3.4Pharmaceutical form Powder for oral solution in sachet
    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 INNLactobacillus casei rhamnosus (LCR 35)
    D.3.9.3Other descriptive nameLACTOBACILLUS RHAMNOSUS GG
    D.3.9.4EV Substance CodeSUB127064
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number150
    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 placeboPowder for oral solution in sachet
    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
    Helicobacter pylori infection
    E.1.1.1Medical condition in easily understood language
    Helicobacter pylori infection leading to histology-proven chronic gastritis
    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
    Primary:
    To test the hypothesis that H pylori eradication rates of a levofloxacin-based sequencial therapy
    are higher when combining the standard-of-care treatment with Lactobacillus casei rhamnosus,
    strain 35 (LCR 35, group A) than with placebo (group B) at Week 12.
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of a levofloxacin-based sequential therapy in combination treatment with LCR compared to placebo
    -To study the efficacy of LCR , monotherapy plus ESO compared to placebo
    - To assess the efficacy of monotherapy with LCR plus ESO compared to placebo
    -To evaluate whether a preceding course of LCR monotherapy plus ESO will affect consecutive eradication therapy with a
    levofloxacin-based sequential therapy
    -To assess whether baseline histologic parameters are related with treatment outcomes
    -To assess the occurrence of adverse events related to therapy in all treatment groups based on a modified De-Boer evaluation
    - To evaluate the occurrence of AEs related to therapy based
    on a modified De-Boer evaluation
    -To evaluate the patients’ compliance and the number of pills returned in the treatment box
    -Comparing taxonomic composition, alpha diversity and beta diversity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. Signed the informed consent form
    2. Men or women between 18 and 70 years
    3. Histologically-proven Helicobacter pylori-associated gastritis prior to screening
    4. Helicobacter pylori colonization confirmed by stool antigen test
    5. BMI between 18.5 and 35, inclusively
    6. Negative anamnesis for current pregnancy or breast-feeding at Screening and Baseline
    7. Women at child-bearing potential are advised to use an effective method of birth control
    E.4Principal exclusion criteria
    Exclusion criteria:
    1. History of previous Helicobacter pylori eradication, unless deemed to be irrelevant by the principal investigator (i.e. in cases of a long gap between first eradication and current positive H. pylori result, making reinfection the most propable explanation).
    2. Known intolerances or allergies to any of the study drugs
    3. Severe endoscopic manifestation, such as hemorrhagic gastritis and gastric or duodenal ulcers
    4. Barrett’s oesophagus, high-grade dysplasia, or any kind of malignancy in endoscopy
    5. Use of non-steroidal anti-inflammatory drugs (NSAIDS, exept acetylsalicylic acid if daily dose is
    ≤ 100mg per day), antibiotics, pre- or probiotics within 4 weeks prior to enrollment
    6. History of major abdominal surgery in the past (appendectomy excluded)
    7. History of regular excessive alcohol intake (>40g/d for women, >80g/d for men) or drug abuse
    (steroid-abuse included) within the past 12 months
    8. History of lactose intolerance
    9. Any substantial organ impairment including severe or unstable cardiopulmonary, renal, liver,
    endocrine, or neuro-psychiatric disease
    10. History of cancer in the last five years
    11. History of chronic infectious or immune-deficient diseases
    12. Existing or planned pregnancy or breast-feeding
    13. Difficulty to understand the treatment or to report disease symptoms and adverse effects
    14. Participation in another clinical trial and having received another IMP within the last 30 days prior
    to screening
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients from group A and B achieving a negative Helicobacter stool antigen test at
    Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    -Positivity or negativity for Helicobacter stool antigen at week 52 comparing group A with group B
    -Positivity or negativity for Helicobacter stool antigen at week 12 comparing group C with group D
    -Positivity or negativity for Helicobacter stool antigen at week 52 comparing group C with group D
    -Correlation of Helicobacter eradication efficacy, i.e. positive or negative Helicobacter stool
    antigen test at week 12 with histologic parameters at baseline comparing all groups A to D
    -Treatment-related side effects according to a modified DeBoer scale comparing groups A and B
    or groups C and D at Visit 4 and comparing longitudinal changes from baseline to Visit 4 within
    the same groups
    - Treatment-related side effects according to a modified DeBoer scale comparing groups A and B
    or groups C and D at Visit 5 and comparing longitudinal changes from baseline to Visit 5 and
    Visit 3 within the same groups
    -Treatment compliance derived from the short compliance questionnaire and the number of
    returned medication at Visit 4 comparing groups A and B or C and D.
    -Comparing taxonomic composition, alpha diversity and beta diversity before and shortly after
    Helicobacter-specific treatment in all groups A to D
    -Comparing taxonomic composition, alpha diversity and beta diversity before and 3 months after
    Helicobacter-specific treatment in all groups A to D
    -Comparing taxonomic composition, alpha diversity, and beta diversity before and 12 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 2, 12, 14, 48, 52
    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 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 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 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 trial4
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 440
    F.1.3Elderly (>=65 years) No
    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 state440
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 440
    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)
    Patients from the treatment groups A and B who failed H pylori eradication by having a
    positive Helicobacter stool antigen test at week 12 will be offered a guideline conform
    salvage eradication therapy with Pylera® for 10 days

    Patients from the treatment groups C and D who failed H pylori eradication by having a
    positive Helicobacter stool antigen test at week 12 will be offered a guideline conform
    eradication therapy with a levofloxacin based sequential therapy for 10 days
    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 Decision2019-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
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