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    Clinical Trial Results:
    EFFECT OF STW5 (Iberogast ®) AND STW5-II (Iberogast N®) ON TRANSIT AND TOLERANCE OF INTESTINAL GAS

    Summary
    EudraCT number
    		 2019-003976-38
    Trial protocol
    		 ES  
    Global end of trial date
    31 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2024
    First version publication date
    13 Dec 2024
    Other versions
    Summary report(s)
    		 Part 1 IBS. Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    IBO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04656730
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vall d'Hebron Institut de Recerca (VHIR)
    Sponsor organisation address
    Passeig de la Vall d'Hebron, 119-129,, Barcelona, Spain, 08035
    Public contact
    info@scienhub.org, ScienHub Research Support - CRO, +34 93497 84 14,
    Scientific contact
    info@scienhub.org, ScienHub Research Support - CRO, +34 93497 84 14,
    Sponsor organisation name
    Institut de recerca Germans Trias i Pujol (IGTP)
    Sponsor organisation address
    Carretera Canyet S/N, Badalona, Spain, 08916
    Public contact
    ScienHub Research Support - CRO, ScienHub Research Support - CRO, 34 934978414, info@scienhub.org
    Scientific contact
    ScienHub Research Support - CRO, ScienHub Research Support - CRO, 34 934978414, info@scienhub.org
    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
    25 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the effect of STW5 and STW5-II on transit and evacuation of intestinal gas in subjects with functional dyspepsia and irritable bowel syndrome according to Rome IV criteria.
    Protection of trial subjects
    Not specified
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2020
    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: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants will be recruited at the Gastroenterology Department/HUGTIP and at the Digestive Functional Testing Unit/Hospital Universitari Vall d´Hebrón.

    Pre-assignment
    Screening details
    		 Participants ≥18 years old with Confirmed Irritable Bowel Syndrome (IBS) or Functional Dyspepsia (FD) diagnosis per Rome IV criteria and with active symptoms of bloating.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject
    Blinding implementation details
    A double-blind/masking technique will be used. STW5, STW5-II, and placebo will be packaged identically to maintain blinding. The subject, the investigator, and Sponsor personnel or delegate(s) involved in the subjects' treatment or clinical evaluation are unaware of the group assignments. The Pharmacy Service will dispense the STW5/ STW5-II /placebo to the participant according to the participating codes assigned by the randomization process.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Iberogast (STW5)
    Arm description
    		 STW5 (Iberogast ®): 20 drops three times per day (TID) for 14 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iberogast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    20 drops three times per day (TID) for 14 days

    Arm title
    		 Iberogast Placebo
    Arm description
    		 20 drops three times per day (TID) for 14 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Iberogast Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    20 drops three times per day (TID) for 14 days

    Arm title
    		 Iberogast N (STW5-II)
    Arm description
    		 STW5-II (Iberogast® N): 20 drops three times per day (TID) for 14 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iberogast® N
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    20 drops three times per day (TID) for 14 days

    Arm title
    		 Iberogast N Placebo
    Arm description
    		 20 drops three times per day (TID) for 14 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Iberogast® N Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    20 drops three times per day (TID) for 14 days

    Number of subjects in period 1
    		Iberogast (STW5) Iberogast Placebo Iberogast N (STW5-II) Iberogast N Placebo
    Started
    14
    11
    15
    12
    Completed
    14
    11
    15
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Iberogast (STW5)
    Reporting group description
    		 STW5 (Iberogast ®): 20 drops three times per day (TID) for 14 days

    Reporting group title
    Iberogast Placebo
    Reporting group description
    		 20 drops three times per day (TID) for 14 days

    Reporting group title
    Iberogast N (STW5-II)
    Reporting group description
    		 STW5-II (Iberogast® N): 20 drops three times per day (TID) for 14 days

    Reporting group title
    Iberogast N Placebo
    Reporting group description
    		 20 drops three times per day (TID) for 14 days

    Reporting group values
    		 Iberogast (STW5) Iberogast Placebo Iberogast N (STW5-II) Iberogast N Placebo Total
    Number of subjects
    		 14 11 15 12 52
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 11 10 14 9 44
        From 65-84 years
    		 3 1 1 3 8
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 13 10 14 12 49
        Male
    		 1 1 1 0 3

    End points

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    End points reporting groups
    Reporting group title
    Iberogast (STW5)
    Reporting group description
    		 STW5 (Iberogast ®): 20 drops three times per day (TID) for 14 days

    Reporting group title
    Iberogast Placebo
    Reporting group description
    		 20 drops three times per day (TID) for 14 days

    Reporting group title
    Iberogast N (STW5-II)
    Reporting group description
    		 STW5-II (Iberogast® N): 20 drops three times per day (TID) for 14 days

    Reporting group title
    Iberogast N Placebo
    Reporting group description
    		 20 drops three times per day (TID) for 14 days

    Primary: To compare final gas retention

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    End point title
    		 To compare final gas retention
    End point description
    To compare final gas retention (calculated as total gas infused minus total gas evacuated) after a gas challenge test performed after 2 weeks treatment with Iberogast® or Iberogast N® vs placebo.
    End point type
    Primary
    End point timeframe
    At 2 weeks
    End point values
    		 Iberogast (STW5) Iberogast Placebo Iberogast N (STW5-II) Iberogast N Placebo
    Number of subjects analysed
    14
    11
    15
    12
    Units: Gastric Belching
        arithmetic mean (standard error)
    2.1 ( 4.1 )
    0.8 ( 1.8 )
    1.5 ( 2.4 )
    2.2 ( 3.6 )
    Statistical analysis title
    		 STUDENT T TEST/ WILCOXON SIGNED-RANK TEST
    Statistical analysis description
    The Kolmogorov-Smirnov test will be used to check the normality of data distribution. Comparisons of parametric, normally- distributed data will be performed by ANOVA, and Students t-test will be used for post-hoc comparisons. Non-parametric data will be compared using the Kruskal-Wallis-test, and the Mann-Whitney U test for post-hoc comparisons.
    Comparison groups
    Iberogast (STW5) v Iberogast Placebo v Iberogast N (STW5-II) v Iberogast N Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015 [1]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    173
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8
         upper limit
    		 508
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05
    Notes
    [1] - 0.015 after 20 minutes from infusion starts. Differences will be considered statistically significant when p-value is <0.05.

    Secondary: To compare the perception of abdominal symptoms induced by the gas challenge test

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    End point title
    		 To compare the perception of abdominal symptoms induced by the gas challenge test
    End point description
    To compare the perception of abdominal symptoms induced by the gas challenge test after 2 weeks treatment with Iberogast® or Iberogast N® vs placebo.
    End point type
    Secondary
    End point timeframe
    At 2 weeks
    End point values
    		 Iberogast (STW5) Iberogast Placebo Iberogast N (STW5-II) Iberogast N Placebo
    Number of subjects analysed
    14
    11
    15
    12
    Units: Score
        arithmetic mean (standard deviation)
    0.7 ( 0.4 )
    2.2 ( 0.5 )
    0.8 ( 0.4 )
    1.4 ( 0.6 )
    No statistical analyses for this end point

    Secondary: To compare the objective abdominal distension (measured by a tape measure) induced by the gas challenge test

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    End point title
    		 To compare the objective abdominal distension (measured by a tape measure) induced by the gas challenge test
    End point description
    To compare the objective abdominal distension (measured by a tape measure) induced by the gas challenge test after 2 weeks treatment with Iberogast® or Iberogast N® vs placebo.
    End point type
    Secondary
    End point timeframe
    At 2 weeks
    End point values
    		 Iberogast (STW5) Iberogast Placebo Iberogast N (STW5-II) Iberogast N Placebo
    Number of subjects analysed
    14
    11
    15
    12
    Units: mm
        arithmetic mean (standard deviation)
    10 ( 3 )
    10 ( 3 )
    8 ( 3 )
    9 ( 2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Iberogast (STW5)
    Reporting group description
    		 STW5 (Iberogast ®): 20 drops three times per day (TID) for 14 days

    Reporting group title
    Iberogast Placebo
    Reporting group description
    		 20 drops three times per day (TID) for 14 days

    Reporting group title
    Iberogast N (STW5-II)
    Reporting group description
    		 STW5-II (Iberogast® N): 20 drops three times per day (TID) for 14 days

    Reporting group title
    Iberogast N Placebo
    Reporting group description
    		 20 drops three times per day (TID) for 14 days

    Serious adverse events
    		 Iberogast (STW5) Iberogast Placebo Iberogast N (STW5-II) Iberogast N Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Iberogast (STW5) Iberogast Placebo Iberogast N (STW5-II) Iberogast N Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
    4 / 15 (26.67%)
    3 / 12 (25.00%)
    General disorders and administration site conditions
    Abdominal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Colonic bleeding
    Additional description: Mild colonic bleeding during a colonic polypectomy that required no treatment
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
    2 / 15 (13.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Renal and urinary disorders
    Urine tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Apr 2021
    Sponsor Modification (Vall d'Hebron Institut de Recerca (VHIR)) and addition of a new study site (HOSPITAL UNIVERSITARI VALL D'HEBRON).

    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.
    The study IBO consists of two substudies (Part 1: IBS) and (Part 2), with the same EudraCT. The full data set has been completed for the phase 2 study as it is not possible to add the full data set for both studies. See the summary attached.
    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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