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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled study of the usefulness of the probiotic 'Lactobacillus reuteri' in the therapy of quadruple eradication of Helicobacter pylori infection in usual clinical practice

    Summary
    EudraCT number
    2017-000342-22
    Trial protocol
    ES  
    Global end of trial date
    01 Aug 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Apr 2020
    First version publication date
    17 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VALACT-2017-01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Dr. Luis Fernández-Dr. Jesus Barrio
    Sponsor organisation address
    Hosp Clín Univ Valladolid-Hosp Univ Río Hortega Valladolid, Valladolid, Spain,
    Public contact
    Dr. Jesus Barrio Hosp Univ Río Hortega Valladolid, Dr. Luis Fernández Hosp Clín Univ Valladolid , +34 9999999, jbarrioa95@gmail.com
    Scientific contact
    Dr. Jesus Barrio Hosp Univ Río Hortega Valladolid, Dr. Luis Fernández Hosp Clín Univ Valladolid , +34 9999999, jbarrioa95@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
    14 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To know if supplementation with Gastrus (food supplement) vs Placebo is able of lowering the gastrointestinal adverse effects of quadruple eradication therapy determined by the GSRS gastrointestinal symptom scale in routine clinical practice.
    Protection of trial subjects
    The study was in compliance with ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    Eradicator treatment with quadruple therapy (at the discretion of the responsible physician): - Quadruple with bismuth: Pylera (three in one tablets: bismuth, tetracyclines and metronidazole): 3 tablets every 6 hours and omeprazole of 20 mg 1 tablet every 12 hours for 10 consecutive days. - Quadruple without bismuth: Esomeprazole 40 mg 1 tablet every 12 hours, Amoxicillin 1 g every 12 hours, Clarithromycin 500 mg every 12 hours, Metronidazole 500 mg every 12 hours, all for 14 consecutive days.
    Evidence for comparator
    Placebo-controlled study to confirm the usefulness of the probiotic 'Lactobacillus reuteri'
    Actual start date of recruitment
    01 Jan 2017
    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
    Spain: 86
    Worldwide total number of subjects
    86
    EEA total number of subjects
    86
    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)
    79
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Two centers involved and 86 subjects participated in the study. Data collection began in January 2017 and ended in August 2018. Seven subjects did not meet the age inclusion criteria and two subjects did not meet the exclusion criterion 3 “Patient treated with NSAIDs”, so their data is not analysed. 77 subjects were declared valid for analysis.

    Pre-assignment
    Screening details
    Aged 18-65 years; Positive diagnosis of H pylori infection.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    All study treatments were supplied in a way in that they are indistinguishable from each other, in order to maintain the masking of the clinical trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Gastrus
    Arm description
    Gastrus (a dietary supplement containing Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 6475). The daily Gastrus dose was one tablet per day (2x108 UFC). It was administered from the first day of the eradicator treatment until completing 30 days of treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    Gastrus
    Investigational medicinal product code
    Other name
    Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 6475
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily Gastrus dose was one tablet per day (2x108 UFC). It was administered from the first day of the eradicator treatment until completing 30 days of treatment.

    Arm title
    Placebo
    Arm description
    The daily placebo dose was one tablet per day. It was administered from the first day of the eradicator treatment until completing 30 days of treatment.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily placebo dose was one tablet per day. It was administered from the first day of the eradicator treatment until completing 30 days of treatment.

    Number of subjects in period 1 [1]
    Gastrus Placebo
    Started
    36
    41
    Completed
    36
    41
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Seven subjects did not meet the age inclusion criteria, not exceeding 65 years, so their data is not analysed. In a subject, the exclusion criterion 3 “The patient is treated with NSAIDs” was not specified, so that subject is not considered valid for analysis either. Another patient was treated with NSAIDs, which is also excluded from the analysis. 77 subjects were declared valid for analysis.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gastrus
    Reporting group description
    Gastrus (a dietary supplement containing Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 6475). The daily Gastrus dose was one tablet per day (2x108 UFC). It was administered from the first day of the eradicator treatment until completing 30 days of treatment.

    Reporting group title
    Placebo
    Reporting group description
    The daily placebo dose was one tablet per day. It was administered from the first day of the eradicator treatment until completing 30 days of treatment.

    Reporting group values
    Gastrus Placebo Total
    Number of subjects
    36 41 77
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    51.5 (23 to 64) 44 (19 to 63) -
    Gender categorical
    Units: Subjects
        Female
    20 28 48
        Male
    16 13 29
    Received therapy
    Units: Subjects
        Quadruple therapy with bismuth
    24 27 51
        Quadruple therapy without bismuth
    12 14 26
    GSRS total score
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    Units: points (range: 0-45)
        arithmetic mean (standard deviation)
    6.69 ± 4.28 6.46 ± 4.21 -
    GSRS score: Pain syndrome
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    Units: points (range: 0-3)
        arithmetic mean (standard deviation)
    0.31 ± 0.47 0.34 ± 0.58 -
    GSRS score: Dyspeptic syndrome
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    Units: points (range: 0-12)
        arithmetic mean (standard deviation)
    2.47 ± 1.95 1.78 ± 1.64 -
    GSRS score: Indigestion syndrome
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    Units: points (range: 0-12)
        arithmetic mean (standard deviation)
    2.92 ± 2.1 2.78 ± 2.2 -
    GSRS score: Colon disfunction syndrome
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    Units: points (range: 0-18)
        arithmetic mean (standard deviation)
    1.0 ± 1.45 1.56 ± 1.61 -

    End points

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    End points reporting groups
    Reporting group title
    Gastrus
    Reporting group description
    Gastrus (a dietary supplement containing Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 6475). The daily Gastrus dose was one tablet per day (2x108 UFC). It was administered from the first day of the eradicator treatment until completing 30 days of treatment.

    Reporting group title
    Placebo
    Reporting group description
    The daily placebo dose was one tablet per day. It was administered from the first day of the eradicator treatment until completing 30 days of treatment.

    Primary: Change GSRS at day 15 from baseline: Total score

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    End point title
    Change GSRS at day 15 from baseline: Total score
    End point description
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    End point type
    Primary
    End point timeframe
    At day 15 of treatment
    End point values
    Gastrus Placebo
    Number of subjects analysed
    36
    37
    Units: points
    arithmetic mean (standard deviation)
        Total score
    0.11 ± 4.51
    -0.57 ± 4.68
    Statistical analysis title
    Differences between groups
    Comparison groups
    Placebo v Gastrus
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.532
    Method
    ANOVA
    Confidence interval

    Secondary: Change GSRS at day 15 from baseline: Pain syndrome

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    End point title
    Change GSRS at day 15 from baseline: Pain syndrome
    End point description
    End point type
    Secondary
    End point timeframe
    At day 15
    End point values
    Gastrus Placebo
    Number of subjects analysed
    35
    37
    Units: points
        arithmetic mean (standard deviation)
    0.14 ± 0.65
    0.11 ± 0.84
    Statistical analysis title
    Differences between groups
    Comparison groups
    Gastrus v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.846
    Method
    ANOVA
    Confidence interval

    Secondary: Change GSRS at day 15 from baseline: Dyspeptic syndrome

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    End point title
    Change GSRS at day 15 from baseline: Dyspeptic syndrome
    End point description
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    End point type
    Secondary
    End point timeframe
    At day 15
    End point values
    Gastrus Placebo
    Number of subjects analysed
    35
    37
    Units: points
        arithmetic mean (standard deviation)
    -0.89 ± 2.26
    -0.24 ± 2.14
    Statistical analysis title
    Differences between groups
    Comparison groups
    Gastrus v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.219
    Method
    ANOVA
    Confidence interval

    Secondary: Change GSRS at day 15 from baseline: Indigestion syndrome

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    End point title
    Change GSRS at day 15 from baseline: Indigestion syndrome
    End point description
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    End point type
    Secondary
    End point timeframe
    At day 15
    End point values
    Gastrus Placebo
    Number of subjects analysed
    35
    37
    Units: points
        arithmetic mean (standard deviation)
    -0.60 ± 1.96
    -0.95 ± 2.11
    Statistical analysis title
    Differences between groups
    Comparison groups
    Placebo v Gastrus
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.474
    Method
    ANOVA
    Confidence interval

    Secondary: Change GSRS at day 15 from baseline: Colon dysfunction syndrome

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    End point title
    Change GSRS at day 15 from baseline: Colon dysfunction syndrome
    End point description
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    End point type
    Secondary
    End point timeframe
    At dat 15
    End point values
    Gastrus Placebo
    Number of subjects analysed
    35
    37
    Units: points
        arithmetic mean (standard deviation)
    1.45 ± 1.77
    0.51 ± 2.05
    Statistical analysis title
    Differences between groups
    Comparison groups
    Gastrus v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.41
    Method
    ANOVA
    Confidence interval

    Secondary: Change GSRS at day 31 from baseline: Total score

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    End point title
    Change GSRS at day 31 from baseline: Total score
    End point description
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    End point type
    Secondary
    End point timeframe
    Overall period
    End point values
    Gastrus Placebo
    Number of subjects analysed
    34
    36
    Units: points
        arithmetic mean (standard deviation)
    -1.82 ± 3.59
    -2.36 ± 4.48
    Statistical analysis title
    Differences between groups
    Comparison groups
    Gastrus v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.583
    Method
    ANOVA
    Confidence interval

    Secondary: Change GSRS at day 31 from baseline: Pain syndrome

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    End point title
    Change GSRS at day 31 from baseline: Pain syndrome
    End point description
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    End point type
    Secondary
    End point timeframe
    Overall period
    End point values
    Gastrus Placebo
    Number of subjects analysed
    34
    36
    Units: points
        arithmetic mean (standard deviation)
    -0.12 ± 0.48
    -0.11 ± 0.67
    Statistical analysis title
    Differences between groups
    Comparison groups
    Gastrus v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.963
    Method
    ANOVA
    Confidence interval

    Secondary: Change GSRS at day 31 from baseline: Dyspeptic syndrome

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    End point title
    Change GSRS at day 31 from baseline: Dyspeptic syndrome
    End point description
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    End point type
    Secondary
    End point timeframe
    Overall period
    End point values
    Gastrus Placebo
    Number of subjects analysed
    34
    36
    Units: points
        arithmetic mean (standard deviation)
    -1.23 ± 2.24
    -0.83 ± 1.59
    Statistical analysis title
    Differences between groups
    Comparison groups
    Gastrus v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.389
    Method
    ANOVA
    Confidence interval

    Secondary: Change GSRS at day 31 from baseline: Indigestion syndrome

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    End point title
    Change GSRS at day 31 from baseline: Indigestion syndrome
    End point description
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    End point type
    Secondary
    End point timeframe
    Overall period
    End point values
    Gastrus Placebo
    Number of subjects analysed
    34
    36
    Units: points
        arithmetic mean (standard deviation)
    -0.79 ± 1.70
    -1.17 ± 2.26
    Statistical analysis title
    Differences between groups
    Comparison groups
    Gastrus v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.441
    Method
    ANOVA
    Confidence interval

    Secondary: Change GSRS at day 31 from baseline: Colon dysfunction syndrome

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    End point title
    Change GSRS at day 31 from baseline: Colon dysfunction syndrome
    End point description
    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific questionnaire for patients with gastrointestinal symptoms. The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. Each item range from 1 to 3 and higher scores represent more discomfort. It has 4 subscales (Pain Syndrome, Dyspeptic syndrome, Indigestion Syndrome, Colon dysfunction syndrome).
    End point type
    Secondary
    End point timeframe
    Overall period
    End point values
    Gastrus Placebo
    Number of subjects analysed
    34
    36
    Units: points
        arithmetic mean (standard deviation)
    0.323 ± 1.57
    -0.25 ± 1.85
    Statistical analysis title
    Differences between groups
    Comparison groups
    Gastrus v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.169
    Method
    ANOVA
    Confidence interval

    Secondary: Eradication rates

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    End point title
    Eradication rates
    End point description
    Porcentaje de pacientes que hayan erradicado mediante el test diagnóstico del test del aliento entre 4 y 8 semanas semanas tras la terminación del tratamiento con el probiótico o placebo.
    End point type
    Secondary
    End point timeframe
    At day 59
    End point values
    Gastrus Placebo
    Number of subjects analysed
    36
    41
    Units: subjects
        Positive
    32
    36
        Negative
    4
    5
    Statistical analysis title
    Differences between groups
    Comparison groups
    Gastrus v Placebo
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8745
    Method
    Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall period
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Gastrus
    Reporting group description
    Gastrus (a dietary supplement containing Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 6475). The daily Gastrus dose was one tablet per day (2x108 UFC). It was administered from the first day of the eradicator treatment until completing 30 days of treatment

    Reporting group title
    Placebo
    Reporting group description
    The daily placebo dose was one tablet per day. It was administered from the first day of the eradicator treatment until completing 30 days of treatment.

    Serious adverse events
    Gastrus Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 41 (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%
    Non-serious adverse events
    Gastrus Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 36 (25.00%)
    5 / 41 (12.20%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 36 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    Abdominal pain
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Breath odour
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    Dysgeusia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    2 / 36 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    2
    0
    Fungal infection
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2

    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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