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    Clinical Trial Results:
    Effect of Proton Pump Inhibitors on the duodenal microbiome in Functional Dyspepsia patients

    Summary
    EudraCT number
    		 2017-004355-23
    Trial protocol
    		 BE  
    Global end of trial date
    22 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Dec 2020
    First version publication date
    28 Dec 2020
    Other versions
    Summary report(s)
    		 Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    PPI-microbiome-FD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03545243
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    TARGID, TARGID, KU Leuven, 32 16372093, Tim.vanuytsel@kuleuven.be
    Scientific contact
    TARGID, TARGID, KU Leuven, 32 16372093, Tim.vanuytsel@kuleuven.be
    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
    22 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of Proton Pump Inhibitors (PPI) on the duodenal, oral and fecal microbiota composition in FD patients before and after start PPI during 4 weeks (FD cohort 1)
    Protection of trial subjects
    local and optional IV sedation with endoscopy local sedation and radioprotection with nasoduodenal tube
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 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
    Belgium: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    49
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All data were collected at KU Leuven and University Hospitals Leuven (Leuven, Belgium) between April 2018 - April 2020

    Pre-assignment
    Screening details
    		 patients with predominant FD symptoms, diagnosed according to Rome IV criteria. Patients were divided in 2 cohorts based on current or previous use of PPI-therapy: (1) “FD-starters” with no standard course of PPI-therapy (4 weeks healing dose) and/or acid suppression < 3 months before inclusion, and (2) “FD-stoppers” with refractory symptoms.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FD-starters
    Arm description
    		 Study procedures were performed before and after start PPI-therapy (pantoprazole 40mg OD for 4 weeks) in FD-starters
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pantomed
    Investigational medicinal product code
    A02BC02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pantomed 40mg once daily for 4 weeks

    Arm title
    		 FD-stoppers
    Arm description
    		 Study procedures were performed before and after PPI-withdrawal in FD-stoppers (8 weeks)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		FD-starters FD-stoppers
    Started
    30
    19
    Completed
    27
    18
    Not completed
    3
    1
         Pregnancy
    1
    -
         Protocol deviation
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FD-starters
    Reporting group description
    		 Study procedures were performed before and after start PPI-therapy (pantoprazole 40mg OD for 4 weeks) in FD-starters

    Reporting group title
    FD-stoppers
    Reporting group description
    		 Study procedures were performed before and after PPI-withdrawal in FD-stoppers (8 weeks)

    Reporting group values
    		 FD-starters FD-stoppers Total
    Number of subjects
    		 30 19 49
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 30 19 49
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 25 14 39
        Male
    		 5 5 10

    End points

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    End points reporting groups
    Reporting group title
    FD-starters
    Reporting group description
    		 Study procedures were performed before and after start PPI-therapy (pantoprazole 40mg OD for 4 weeks) in FD-starters

    Reporting group title
    FD-stoppers
    Reporting group description
    		 Study procedures were performed before and after PPI-withdrawal in FD-stoppers (8 weeks)

    Primary: Eosinophils

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    End point title
    		 Eosinophils [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    before and after 4 weeks of pantomed 40mg once daily
    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: See attached chart with statistical analyses
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: See attached chart with statistical analyses
    End point values
    		 FD-starters
    Number of subjects analysed
    30
    Units: per mm2
        number (not applicable)
    30
    Attachments
    		 within-group change in eosinophils
    No statistical analyses for this end point

    Secondary: Symptoms

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    End point title
    		 Symptoms [3]
    End point description
    End point type
    Secondary
    End point timeframe
    before and after 4 weeks of pantomed 40mg once daily
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: See attached chart with statistical analyses
    End point values
    		 FD-starters
    Number of subjects analysed
    30
    Units: PAGI-SYM
        number (not applicable)
    30
    Attachments
    		 within-group change in symptoms
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    before and after 4 weeks of pantomed 40mg once daily
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    4
    Frequency threshold for reporting non-serious adverse events: 5%
    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: There were no serious adverse events.

    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
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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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