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    Clinical Trial Results:
    insulin resistance, obesity and gastrointestinal bacteria

    Summary
    EudraCT number
    		 2015-000197-35
    Trial protocol
    		 IT  
    Global end of trial date
    26 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Feb 2025
    First version publication date
    05 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IR-HP-14-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Sponsor organisation address
    Via Albertoni, 15, Bologna, Italy, 40138, Bologna, Italy,
    Public contact
    Federico Perna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, +39 3471730707, federicoperna73@gmail.com
    Scientific contact
    Federico Perna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, +39 3471730707, federicoperna73@gmail.com
    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
    19 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the effects of the eradication of Helicobacter pylori, in overweight / obese subjects, using as a pharmacological treatment a 10-day standard therapy (40 mg of pantoprazole, 500 mg of clarithromycin, and 1 g of amoxicillin, each administered twice daily) on insulin resistance, with a interventional prospective randomized, placebo-controlled, double-blind study.
    Protection of trial subjects
    No specific protection measures were required due to the specific treatment protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2015
    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
    Italy: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    100
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Once provided written informed consent, two hundred patients were screened for Hp infection by stool antigen immunochromatography. The first 40 and 60 infected and non-infected patients respectively were enrolled in the protocol for a total of 100 patients.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Rice starch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3 capsules twice a day for 10 days

    Arm title
    		 Group Active Treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pantoprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg twice a day for 10 days

    Investigational medicinal product name
    Clarithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg twice a day for 10 days

    Investigational medicinal product name
    Amoxicillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1g twice a day for 10 days

    Arm title
    		 Non treated patients
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Group Placebo Group Active Treatment Non treated patients
    Started
    10
    30
    60
    Completed
    9
    30
    60
    Not completed
    1
    0
    0
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 100 100
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 100 100
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 51 51
        Male
    		 49 49

    End points

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    End points reporting groups
    Reporting group title
    Group Placebo
    Reporting group description
    		 -

    Reporting group title
    Group Active Treatment
    Reporting group description
    		 -

    Reporting group title
    Non treated patients
    Reporting group description
    		 -

    Primary: Improvement of HOMA index

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    End point title
    		 Improvement of HOMA index
    End point description
    End point type
    Primary
    End point timeframe
    6 weeks
    End point values
    		 Group Placebo Group Active Treatment Non treated patients
    Number of subjects analysed
    9
    30
    0 [1]
    Units: subjects
    5
    12
    Notes
    [1] - Endpoint has not been measured because no control visit was performed.
    Statistical analysis title
    		 Statistical differences in metabolic variables
    Comparison groups
    Group Placebo v Group Active Treatment
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    6 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Group Placebo
    Reporting group description
    		 -

    Reporting group title
    Group Active Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Group Placebo Group Active Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Group Placebo Group Active Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 30 (0.00%)
    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: The short period of treatment has not caused any adverse event.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
    For support, Contact us.
    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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