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    Summary
    EudraCT Number:2015-003944-38
    Sponsor's Protocol Code Number:15-PP-13
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-18
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-003944-38
    A.3Full title of the trial
    Treatment of the oral aphtose récidivante and idiopathique of the adult by probiotics
    Double-blind randomized interventional study versus placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment(Processing) of the oral aphtose récidivante and idiopathique of the adult by probiotics
    A.3.2Name or abbreviated title of the trial where available
    Aphtose
    A.4.1Sponsor's protocol code number15-PP-13
    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 SponsorCHU NICE
    B.1.3.4CountryFrance
    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 supportCHU de Nice
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nice
    B.5.2Functional name of contact pointMme Caillon
    B.5.3 Address:
    B.5.3.1Street AddressDRCI - 4 avenue reine victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06001
    B.5.3.4CountryFrance
    B.5.4Telephone number0033492034589
    B.5.5Fax number0033429034075
    B.5.6E-mailcaillon.c@chu-nice.fr
    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 Bacilor Lactobacillus casei variété rhamnosus Lcr35®
    D.2.1.1.2Name of the Marketing Authorisation holderBacilor
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameBacilor Lactobacillus casei variété rhamnosus Lcr35®
    D.3.2Product code Probionov
    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.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 and solvent 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
    aphtous stoma
    E.1.1.1Medical condition in easily understood language
    aphtous
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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 evaluate the effectiveness of a probiotic (Lactobacillus rhamnosus Lcr35®, Bacilor®) for the treatment of recurrent and idiopathic aphtous stomatitis compared to placebo after 3 months of treatment (M3)
    E.2.2Secondary objectives of the trial
    1 / To evaluate the effectiveness of a probiotic (Lactobacillus rhamnosus Lcr35®, Bacilor®) for the treatment of recurrent and idiopathic aphtous stomatitis compared to placebo 3 months after the discontinuation of the treatment (M6)
    2 / To evaluate the effectiveness on the pain of a probiotic (Lactobacillus rhamnosus Lcr35®, Bacilor®) for the treatment of recurrent and idiopathic aphtous stomatitis compared to placebo after 3 months of treatment (M3) and 3 months after the discontinuation of the treatment (M6).
    3 / To compare the satisfaction of the patients on the efficiency and safety of the treatments after 3 months of treatment (M3)
    4 / To evaluate the impact on quality of life of a probiotic (Lactobacillus rhamnosus Lcr35®, Bacilor®) for the treatment of recurrent and idiopathic aphtous stomatitis compared to placebo after 3 months of treatment (M3) and 3 months after the discontinuation of the treatment (M6).
    5 / To study the possible side effects during treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients older than 18 years old with recurrent and idiopathic aphtous stomatitis. They must have a medical history of recurrent minor aphthous ulcer for at least 6 months with a frequency of at least 1 flare per month
    E.4Principal exclusion criteria
    Use of a probiotic for any other reason. Immunosuppression. Aphtous ulcers as manifestation of systemic disorders such as ulcerative colitis, Crohn disease, Behcet syndrome. Use of medications such as systemic steroids or immunomodulatory agents or colchicine during the last 3 months.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the monthly number of new aphtous ulcers (incidental events) during the 3 months of treatment (D0, M1, M2 and M3 )
    E.5.1.1Timepoint(s) of evaluation of this end point
    at D0, M1, M2 and M3
    E.5.2Secondary end point(s)
    1 / The monthly number of new aphtous ulcers (incidental events) during the 3 months of follow up without treatment (M4, M5 and M6)

    2 / The average monthly pain evaluated by analogical visual scale during the 3 months of treatment (M1, M2 and M3)

    3 / The satisfaction of the patients on the efficiency and the safety of the treatments after 3 months of treatment (M3) evaluated on a visual analogical scale

    4 / The oral health-related quality of life evaluated with the Oral Health Impact Profile 14 after 3 months of treatment (M3) and 3 months after the discontinuation of the treatment (M6).

    5 / The frequency, severity and occurrence of side effects will be noted.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 / During the 3 months of follow up without treatment (M4, M5 and M6)

    2 / During the 3 months of treatment (M1, M2 and M3)

    3 / After 3 months of treatment (M3) evaluated on a visual analogical scale

    4 / At M3 and 3 months after the discontinuation of the treatment (M6).

    5 / At each visit
    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 No
    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 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
    Study end when the report is final after data analysis
    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
    E.8.9.2In all countries concerned by the trial years2
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 2016-01-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 state40
    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)
    At the end of the study, patient wil not have the studied treatment and
    will be followed as usual for is pathology.
    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 Decision2016-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-02
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