Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Comparison of two methods for in vivo diagnosis of Helicobacter pylori infection, by means of a tablet of 13C-Urea.

    Summary
    EudraCT number
    		 2016-001598-33
    Trial protocol
    		 IT  
    Global end of trial date
    29 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Feb 2018
    First version publication date
    15 Feb 2018
    Other versions
    Summary report(s)
    		 Clinical Trial Summary Report

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PSC-DS-BRETEX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    SOFAR S.p.A.
    Sponsor organisation address
    Via Firenze 40, Trezzano Rosa, Italy, 20060
    Public contact
    Divisione Medica, SOFAR S.p.A., +39 029093621, laura.patrucco@sofarfarm.it
    Scientific contact
    Divisione Medica, SOFAR S.p.A., +39 029093621, laura.patrucco@sofarfarm.it
    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
    31 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Concordance between the results obtained with the two methods in the diagnosis of H. pylori
    Protection of trial subjects
    Participation in the study did not entail any additional risk for patients than would have been expected with the execution of the examination with a single method, as only one 100 mg tablet of EXPIROBACTER® was taken, dissolved in a solution in which a 1.4 g sachet of citric acid was dissolved. The patients had indication to perform urea Breath tests for the determination of H. pylori infection. Once the marker was taken, non-invasive methods of expired air sampling were performed. The risks associated with intake are limited to a possible not known intolerance to EXPIROBACTER® or citric acid. In any case, these are limited risks, which are acceptable against the benefit of accessing a non-invasive diagnostic evaluation.
    Background therapy
    		 None
    Evidence for comparator
    		 The different distribution of the isotopes ¹³C (carbon-13) and ¹²C (carbon-12) in the molecules of exhaled carbon dioxide, expressed as ¹²C/¹³C ratio, gives a rationale for ¹³C-based test. In normal conditions, the assumption of urea enriched in ¹³C does not change ¹²C/¹³C ratio, because only 1% of the carbon is represented by ¹³C. Conversely, in case of H. pylori infection, the assumption of ¹³C-urea changes the ¹²C/¹³C ratio, since the presence of the bacterium increases urease activity, leading to the formation of ¹³C carbon dioxide. ¹³C carbon dioxide passes to the blood and can be measured by exhaled breath analysis.
    Actual start date of recruitment
    22 Nov 2016
    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: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    45
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients have been recruited between 22-Nov-2016 and 29-Dec-2016 in an Italian clinical site.

    Pre-assignment
    Screening details
    		 Subjects enrolled underwent to Urea Breath Test, performed with EXPIROBACTER®, to confirm or exclude H. pylori infection. Subjects were fasting and did not take food or drink or smoke during the duration of the examination. All patients performed, during the same session, the test with the two different methods.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The patients were diagnosed using both methods. Blinding was not needed.

    Arms
    Arm title
    		 Classic and BreathID Method
    Arm description
    		 The patients underwent the breath test using both the classic method, requiring basal exhalation sampling before EXPIROBACTER® ingestion and a second exhalation sampling 30 minutes after, according to the Summary of the Product Characteristics, and a second method based on a continuous analysis of exhaled breath performed by Exalenz BreathID medical device.
    Arm type
    		 Both Experimental and Comparator

    Investigational medicinal product name
    EXPIROBACTER ® 100 mg.
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The patient was administered orally 1 tablet of 100 mg of EXPIROBACTER®, dissolved in a solution in which a 1.4 g sachet of citric acid was solubilized.

    Number of subjects in period 1
    		Classic and BreathID Method
    Started
    46
    Completed
    46

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 46 46
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 45 45
        From 65-84 years
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.22 ± 11.48 -
    Gender categorical
    Units: Subjects
        Female
    		 36 36
        Male
    		 10 10
    Previous H. pylori test
    The presence of any H. pylori test previously performed was reported, together with the result of the test (positive/negative)
    Units: Subjects
        No
    		 38 38
        Yes - Positive
    		 4 4
        Yes - Negative
    		 4 4
    Symptoms leading to the current test for H. pylori
    The presence of at least one symptoms leading to the current test for H. Pylori was registered
    Units: Subjects
        No symptoms
    		 32 32
        At least one symptom
    		 14 14
    Subject analysis sets

    Subject analysis set title
    BreathID
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The patients underwent the breath test using a method based on a continuous analysis of exhaled breath performed by Exalenz BreathID medical device.

    Subject analysis set title
    Classic method
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The patients underwent the breath test using the classic method, requiring basal exhalation sampling before EXPIROBACTER® ingestion and a second exhalation sampling 30 minutes after, according to the Summary of the Product Characteristics

    Subject analysis sets values
    		 BreathID Classic method
    Number of subjects
    46
    46
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    45
    45
        From 65-84 years
    1
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    32.22 ± 11.48
    32.22 ± 11.48
    Gender categorical
    Units: Subjects
        Female
    36
    36
        Male
    10
    10
    Previous H. pylori test
    The presence of any H. pylori test previously performed was reported, together with the result of the test (positive/negative)
    Units: Subjects
        No
    38
    38
        Yes - Positive
    4
    4
        Yes - Negative
    4
    4
    Symptoms leading to the current test for H. pylori
    The presence of at least one symptoms leading to the current test for H. Pylori was registered
    Units: Subjects
        No symptoms
    32
    32
        At least one symptom
    14
    14

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Classic and BreathID Method
    Reporting group description
    		 The patients underwent the breath test using both the classic method, requiring basal exhalation sampling before EXPIROBACTER® ingestion and a second exhalation sampling 30 minutes after, according to the Summary of the Product Characteristics, and a second method based on a continuous analysis of exhaled breath performed by Exalenz BreathID medical device.

    Subject analysis set title
    BreathID
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The patients underwent the breath test using a method based on a continuous analysis of exhaled breath performed by Exalenz BreathID medical device.

    Subject analysis set title
    Classic method
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The patients underwent the breath test using the classic method, requiring basal exhalation sampling before EXPIROBACTER® ingestion and a second exhalation sampling 30 minutes after, according to the Summary of the Product Characteristics

    Primary: Evaluation of results concordance

    		 Close Top of page
    End point title
    		 Evaluation of results concordance [1]
    End point description
    The primary endpoint of this study was the evaluation of the overlap between the results obtained by molecular correlation spectrometry (BreathID) and those obtained by mass spectrometry (classic method) to perform H. pylori test. The concordance (agreement) between the two methods was assessed using Cohen's kappa. Correlation between the two methods was excellent: both methods allowed to identify 41 negative and 5 positive patients (K=1.00) (Table 1).
    End point type
    Primary
    End point timeframe
    The diagnosis was performed with both methods at the same time
    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: The primary analysis was an agreement analysis between the two diagnostic metods using Cohen's kappa. It was not possible to report the results of such a statistical analysis in the Clinical Trials Register. Results are repoted in the attached Table 1.
    End point values
    		 Classic and BreathID Method BreathID Classic method
    Number of subjects analysed
    46
    46
    46
    Units: concordant tests
    46
    46
    46
    Attachments
    		 Table 1 - Concordance between the two methods
    No statistical analyses for this end point

    Secondary: Patient's satisfaction

    		 Close Top of page
    End point title
    		 Patient's satisfaction
    End point description
    Patient's satisfaction was measured by a Visual Analogue Scale (0-100 mm).
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 BreathID Classic method
    Number of subjects analysed
    46
    46
    Units: mm
        arithmetic mean (standard deviation)
    90.17 ± 8.54
    82.35 ± 16.52
    Statistical analysis title
    		 T-test on mean patient's satisfaction
    Statistical analysis description
    The mean patient's satisfaction with the classic method and the BreathID, was compared.
    Comparison groups
    BreathID v Classic method
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [2]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.35
         upper limit
    		 12.3
    Notes
    [2] - The difference between the two diagnostic methods was statistically significant at p < 0.01

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were to be reported during the duration of the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Classic and BreathID Method
    Reporting group description
    		 The patients underwent the breath test using both the classic method, requiring basal exhalation sampling before EXPIROBACTER® ingestion and a second exhalation sampling 30 minutes after, according to the Summary of the Product Characteristics, and a second method based on a continuous analysis of exhaled breath performed by Exalenz BreathID medical device.

    Serious adverse events
    		 Classic and BreathID Method
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 46 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Classic and BreathID Method
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 46 (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: No adverse event occurred during the study.

    More information

    		 Close Top of page

    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.

    European Medicines Agency © 1995-Fri Apr 26 12:35:23 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA