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    Clinical Trial Results:
    Treatment of the oral aphtose récidivante and idiopathique of the adult by probiotics Double-blind randomized interventional study versus placebo

    Summary
    EudraCT number
    		 2015-003944-38
    Trial protocol
    		 FR  
    Global end of trial date
    24 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jun 2022
    First version publication date
    16 Jun 2022
    Other versions
    Summary report(s)
    		 end study
    Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    15-PP-13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    chu de nice
    Sponsor organisation address
    DRCI-Hôpital de Cimiez - 4 avenue reine victoria, Nice, France, 06003
    Public contact
    Mme Caillon, CHU de Nice, 00 33492034589, caillon.c@chu-nice.fr
    Scientific contact
    Pr Thierry Passeron, CHU de Nice, 0492034589 33492036488, passeron.t@chu-nice.fr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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)
    Protection of trial subjects
    19 patients were randomized and signed consent
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jan 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    16
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Eligible participants were aged 18 or over, with history of RIAS (at least one new aphthous lesion each month during the past 6 months). ter central randomization, patients were allocated to received oral suspension of 1.5 billion Lactobacillus rhamnosus Lcr35 (Bacilor, Lyocentre laboratories) or placebo, four times a day for 3 months

    Period 1
    Period 1 title
    Inclusion Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Arm title
    		 Bacilor or placebo
    Arm description
    		 After central randomization, patients were allocated to received oral suspension of 1.5 billion Lactobacillus rhamnosus Lcr35 (Bacilor, Lyocentre laboratories) or placebo, four times a day for 3 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bacilor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Oral use
    Dosage and administration details
    oral suspension of 1.5 billion Lactobacillus rhamnosus Lcr35 (Bacilor, Lyocentre laboratories) or placebo, four times a day for 3 months.

    Number of subjects in period 1
    		Bacilor or placebo
    Started
    19
    Completed
    19

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Bacilor or placebo
    Reporting group description
    		 After central randomization, patients were allocated to received oral suspension of 1.5 billion Lactobacillus rhamnosus Lcr35 (Bacilor, Lyocentre laboratories) or placebo, four times a day for 3 months.

    Primary: The primary end point was the number of canker sores in the third month of treatment as compared to the month before the onset of the study.

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    End point title
    		 The primary end point was the number of canker sores in the third month of treatment as compared to the month before the onset of the study. [1]
    End point description
    End point type
    Primary
    End point timeframe
    In the third month of treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: It's the difference between the patients with Bacilor and the patients with placebo.
    End point values
    		 Bacilor or placebo
    Number of subjects analysed
    19
    Units: Number
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    6 times (V1, V2, V3 at 3 months, V4, V5, V6 at 6 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No serious side effect was reported.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jan 2017
    Modification de l'étiquette
    11 Jan 2017
    RGPD
    10 Jan 2019
    Diminution of number of patients : 20

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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