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    Clinical Trial Results:
    Double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of „Ensinger Schiller Quelle Heilwasser“ on improvement of bowel function

    Summary
    EudraCT number
    		 2013-000861-36
    Trial protocol
    		 DE  
    Global end of trial date
    26 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jan 2022
    First version publication date
    15 Jan 2022
    Other versions
    Summary report(s)
    		 Synopsis_incl_results_ENS007612

    Trial information

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    Trial identification
    Sponsor protocol code
    ENS/007612
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ensinger Mineral-Heilquellen GmbH
    Sponsor organisation address
    Horrheimer Straße 28-36, Vaihingen-Ensingen, Germany,
    Public contact
    Thomas Fritz, Ensinger Mineral-Heilquellen GmbH, 0049 70422809610, thomas.fritz@ensinger.de
    Scientific contact
    Thomas Fritz, Ensinger Mineral-Heilquellen GmbH, 0049 70422809610, thomas.fritz@ensinger.de
    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
    06 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial is the change of bowel movement frequency per week between baseline and visit 4 compared to placebo.
    Protection of trial subjects
    As no pain and distress was expected no specific measures were taken.
    Background therapy
    		 No other treatments was used across all arms/groups in the trial .
    Evidence for comparator
    		 In order to obtain objective study data and to better assess the effect of the healing water, a placebo was used as a comparator, a product with an identical appearance and similar taste, but with a low concentration of minerals and a CO2 concentration comparable to the verum.
    Actual start date of recruitment
    30 Jul 2013
    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
    Germany: 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
    		 Recruitment take place in Germany at one site in the period from 30. July 2013 until 26. May 2014.

    Pre-assignment
    Screening details
    		 Detailed information provided to the patient by the investigator about the content, benefits and risks of this clinical trial. - written consent of the patient to participate Bowel movements on 2 - 4 days per week during the last 3 months - Functional constipation according to ROM III criteria

    Period 1
    Period 1 title
    visit 2 - 4 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum
    Arm description
    		 50% of all recruited subjects took the investigational drug during the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ensinger Schiller Quelle Heilwasser
    Investigational medicinal product code
    58415.00.00
    Other name
    Pharmaceutical forms
    Oral solution in bottle
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: 250 ml fasting in the morning / 250 ml in the course of the morning / 250 ml approx. 30 min before lunch / 250 ml approx. 30 min before dinner

    Arm title
    		 Placebo
    Arm description
    		 50% of all recruited subjects took the placebo during the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Daily intake of a total of 1 litre (room temperature): - 250 ml on an empty stomach in the morning - 250 ml in the course of the morning - 250 ml approx. 30 min before lunch - 250 ml approx. 30 min before dinner

    Number of subjects in period 1
    		Verum Placebo
    Started
    50
    50
    Completed
    50
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    visit 2 - 4
    Reporting group description
    		 -

    Reporting group values
    		 visit 2 - 4 Total
    Number of subjects
    		 100 100
    Age categorical
    Subjects included has been between 18 and 64 years old.
    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
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.8 ± 11.4 -
    Gender categorical
    Units: Subjects
        Female
    		 85 85
        Male
    		 15 15
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS (full analyses set) population includes all subjects with no major violations (as judged during the data review) of inclusion and exclusion criteria at the timepoint of the enrollment, who have taken the investigational product at least one time and subjects whose benefit parameters are available.

    Subject analysis set title
    Valid Case Analysis Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The VCAS (valid case analyses set) population is composed of all subjects in the FAS popula- tion with no major protocol violations (to be documented during data review).

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety set: All subjects who had consumed the investigational product (IP) at least once (as per diary records) will be included in the safety set.

    Subject analysis sets values
    		 Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects
    100
    69
    100
    Age categorical
    Subjects included has been between 18 and 64 years old.
    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)
    100
    69
    100
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    44.8 ± 11.4
    42.7 ± 11.7
    44.8 ± 11.4
    Gender categorical
    Units: Subjects
        Female
    85
    58
    85
        Male
    15
    11
    15

    End points

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    End points reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 50% of all recruited subjects took the investigational drug during the study.

    Reporting group title
    Placebo
    Reporting group description
    		 50% of all recruited subjects took the placebo during the study.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS (full analyses set) population includes all subjects with no major violations (as judged during the data review) of inclusion and exclusion criteria at the timepoint of the enrollment, who have taken the investigational product at least one time and subjects whose benefit parameters are available.

    Subject analysis set title
    Valid Case Analysis Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The VCAS (valid case analyses set) population is composed of all subjects in the FAS popula- tion with no major protocol violations (to be documented during data review).

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety set: All subjects who had consumed the investigational product (IP) at least once (as per diary records) will be included in the safety set.

    Primary: Change of stool frequency

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    End point title
    		 Change of stool frequency
    End point description
    Change in stool frequency per week between baseline and visit 4 compared to placebo. For this purpose, the stool frequency in the week before the baseline visit is compared with the stool frequency in the week before visit 4 (using the patient diary).
    End point type
    Primary
    End point timeframe
    Between Baseline and visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: Numbers
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Wilcoxon
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Change of stool frequency per week

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    End point title
    		 Change of stool frequency per week
    End point description
    Change in stool frequency per week between baseline and visit 3 compared to placebo. The stool frequency in the week before the baseline visit is compared with the stool frequency in the week before visit 3.
    End point type
    Secondary
    End point timeframe
    Between baseline and visit 3
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: numbers
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Exploratory
    Statistical analysis description
    All primary and secondary endpoints , as well as safety variables and other study-relevant parameters, were explored and analyzed descriptively.
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Changes stoolfrequency during study duration

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    End point title
    		 Changes stoolfrequency during study duration
    End point description
    Change in stool frequency throughout the course of the study.
    End point type
    Secondary
    End point timeframe
    During study duration
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: numbers
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Exploratory
    Comparison groups
    Placebo v Verum
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Changes in stool consistency

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    End point title
    		 Changes in stool consistency
    End point description
    Change in stool consistency between baseline and visit 3 and baseline and visit 4 compared to placebo. Placebo (using Bristol Stool Form Scale questionnaire)
    End point type
    Secondary
    End point timeframe
    Between baseline and visit 3 Between baseline and visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: number of kind of consistency
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Exploratory
    Comparison groups
    Placebo v Verum
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Change in gastrointestinal well-being

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    End point title
    		 Change in gastrointestinal well-being
    End point description
    Change in gastrointestinal well-being between baseline and visit 3 and baseline and visit 4 compared to placebo using the Gastrointestinal Quality of Life Index (GLQI).
    End point type
    Secondary
    End point timeframe
    between baseline and visit 3 and baseline and visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: Score
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Exploratory
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Change in general well-being

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    End point title
    		 Change in general well-being
    End point description
    Change in general well-being between baseline and visit 3 and baseline and visit 4 compared to placebo using SF-12 questionnaire.
    End point type
    Secondary
    End point timeframe
    between baseline and visit 3 and baseline and visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: Score
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Exploratory
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Change in liver function parameters

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    End point title
    		 Change in liver function parameters
    End point description
    Change in liver function parameters between screening visit 1 and visit 4 compared to placebo.
    End point type
    Secondary
    End point timeframe
    between screening visit 1 and visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: Decimal numbers
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Exploratory
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Change in lipid metabolism parameter

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    End point title
    		 Change in lipid metabolism parameter
    End point description
    Change in lipid metabolism parameter between screening visit and visit 4 compared to placebo
    End point type
    Secondary
    End point timeframe
    between screening visit and visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: Decimal numbers
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Exploratory
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Change in intestinal flora parameters

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    End point title
    		 Change in intestinal flora parameters
    End point description
    Change in intestinal flora parameters between screening visit and visit 4 compared to placebo.
    End point type
    Secondary
    End point timeframe
    between screening visit and visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: decimal numbers
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Exploratory
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Change in body weight

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    End point title
    		 Change in body weight
    End point description
    Change in body weight between baseline and visit 3 as well as baseline and visit 4 compared with placebo
    End point type
    Secondary
    End point timeframe
    between baseline and visit 3 as well as baseline and visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: Kilo gramm
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Exploratory
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Change in abdominal and hip circumference

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    End point title
    		 Change in abdominal and hip circumference
    End point description
    Change in abdominal and hip circumference between baseline and visit 3 and baseline and visit 4 compared to placebo.
    End point type
    Secondary
    End point timeframe
    between baseline and visit 3 and baseline and visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: cm
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Exploratory
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Change in blood pressure

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    End point title
    		 Change in blood pressure
    End point description
    Change in blood pressure between baseline and visit 3 and baseline and visit 4 compared to placebo.
    End point type
    Secondary
    End point timeframe
    between baseline and visit 3 and baseline and visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: mm/Hg
        number (not applicable)
    50
    50
    100
    69
    100
    Statistical analysis title
    		 Exploratory
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Global assessment of effectiveness

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    End point title
    		 Global assessment of effectiveness
    End point description
    Global assessment of effectiveness by investigators and Patients on visit 4
    End point type
    Secondary
    End point timeframe
    on visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: numbers
    50
    50
    100
    69
    100
    No statistical analyses for this end point

    Secondary: Global assessment of tolerability

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    End point title
    		 Global assessment of tolerability
    End point description
    Global assessment of tolerability by investigators and patients on visit 4
    End point type
    Secondary
    End point timeframe
    on visit 4
    End point values
    		 Verum Placebo Full Analysis Set Valid Case Analysis Set Safety
    Number of subjects analysed
    50
    50
    100
    69
    100
    Units: Numbers
    50
    50
    100
    69
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From visit 2 until visit 4
    Adverse event reporting additional description
    An adverse event (AE) is any adverse occurrence that happens to an affected person who has been administered an investigational medicinal product and that is not necessarily causally related to this treatment (GCP-V §3 No. 6).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    diarrhoe
    Reporting group description
    		 -

    Reporting group title
    meteorismus
    Reporting group description
    		 -

    Serious adverse events
    		 diarrhoe meteorismus
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (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
    		 diarrhoe meteorismus
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    meteorism
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1

    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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