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    Clinical Trial Results:
    Influence of UDCA on fecal bile salt composition of IBD patients: pilot study

    Summary
    EudraCT number
    		 2014-003141-10
    Trial protocol
    		 BE  
    Global end of trial date
    10 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Dec 2021
    First version publication date
    04 Dec 2021
    Other versions
    Summary report(s)
    		 Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2014/004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.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
    07 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To research the effects of UDCA administration on the fecal metabolites (especially bile salts) and fecal microbiota of IBD patients and healthy volunteers.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 54
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    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)
    52
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 54 patients were screened from 05-06-2015 till 07-09-2016. 54 patients were enrolled. Patients that completed the study could not be determined as 32 CRFs were not completed/available. End of trial notification was dated 07-09-2016 (last patient last visit) and submitted to EC and CA 10-01-2019.

    Pre-assignment
    Screening details
    		 Control group: age between 18-65 yrs, abscence of important gastrointestinal co-morbidity IBD group: Crohn's disease or Colitis ulcerosa, active disease at inclusion (CDAI ≥ 150 or UCDAI ≥ 3) IBD remission group: Crohn's disease or Colitis ulcerosa, Clinical remission (CDAI < 150 or UCDAI ≤ 2) PSC group: known PSC, Chronic treatment with UDCA

    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
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment arm
    Arm description
    		 Two groups of patients were included. All patients received ursodeoxycholic acid: active IBD group (20 individuals), IBD remission group (1 individual)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ursodeoxycholic acid
    Investigational medicinal product code
    Other name
    UrsoFalk
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Per day, 250 mg milligram(s)

    Arm title
    		 No treatment arm
    Arm description
    		 No treatment arm contains the healthy volunteer group (25 individuals) and primary sclerosing cholangitis group (0 individuals).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Unknown
    Arm description
    		 ICF IBD signed but no CRF completed and thus impossible to determine in which group the subjects were enrolled.
    Arm type
    		 unkown

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Treatment arm No treatment arm Unknown
    Started
    21
    25
    8
    Completed
    0
    0
    0
    Not completed
    21
    25
    8
         impossible to determine: 32 CRFs were incomplete
    21
    25
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 Two groups of patients were included. All patients received ursodeoxycholic acid: active IBD group (20 individuals), IBD remission group (1 individual)

    Reporting group title
    No treatment arm
    Reporting group description
    		 No treatment arm contains the healthy volunteer group (25 individuals) and primary sclerosing cholangitis group (0 individuals).

    Reporting group title
    Unknown
    Reporting group description
    		 ICF IBD signed but no CRF completed and thus impossible to determine in which group the subjects were enrolled.

    Reporting group values
    		 Treatment arm No treatment arm Unknown Total
    Number of subjects
    		 21 25 8 54
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 19 25 8 52
        From 65-84 years
    		 2 0 0 2
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 8 12 4 24
        Male
    		 13 13 4 30

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 Two groups of patients were included. All patients received ursodeoxycholic acid: active IBD group (20 individuals), IBD remission group (1 individual)

    Reporting group title
    No treatment arm
    Reporting group description
    		 No treatment arm contains the healthy volunteer group (25 individuals) and primary sclerosing cholangitis group (0 individuals).

    Reporting group title
    Unknown
    Reporting group description
    		 ICF IBD signed but no CRF completed and thus impossible to determine in which group the subjects were enrolled.

    Primary: Change in fecal metabolite composition (especially bile salts)

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    End point title
    		 Change in fecal metabolite composition (especially bile salts) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Until 4 weeks after start of study.
    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: No statistical analysis available
    End point values
    		 Treatment arm No treatment arm Unknown
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: metabolite composition
        number (not applicable)
    Notes
    [2] - Impossible to determine as 32 CRFs were not completed/available.
    [3] - Impossible to determine as 32 CRFs were not completed/available.
    [4] - Impossible to determine as 32 CRFs were not completed/available.
    No statistical analyses for this end point

    Primary: Change in fecal microbiota composition

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    End point title
    		 Change in fecal microbiota composition [5]
    End point description
    End point type
    Primary
    End point timeframe
    Until 4 weeks after start of study.
    Notes
    [5] - 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: No statistical analysis available
    End point values
    		 Treatment arm No treatment arm Unknown
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    Units: microbiota composition
        number (not applicable)
    Notes
    [6] - Impossible to determine as 32 CRFs were not completed/available.
    [7] - Impossible to determine as 32 CRFs were not completed/available.
    [8] - Impossible to determine as 32 CRFs were not completed/available.
    No statistical analyses for this end point

    Secondary: Tolerability of UDCA administration (adverse effects)

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    End point title
    		 Tolerability of UDCA administration (adverse effects)
    End point description
    End point type
    Secondary
    End point timeframe
    Until 4 weeks after start of study.
    End point values
    		 Treatment arm No treatment arm Unknown
    Number of subjects analysed
    0 [9]
    0 [10]
    0 [11]
    Units: adverse effects
    Notes
    [9] - Impossible to determine as 32 CRFs were not completed/available.
    [10] - Impossible to determine as 32 CRFs were not completed/available.
    [11] - Impossible to determine as 32 CRFs were not completed/available.
    No statistical analyses for this end point

    Secondary: Change in CDAI/UCDAI score, calprotectin levels

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    End point title
    		 Change in CDAI/UCDAI score, calprotectin levels
    End point description
    End point type
    Secondary
    End point timeframe
    Until 4 weeks after start of study.
    End point values
    		 Treatment arm No treatment arm Unknown
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    Units: calprotectin levels
        number (not applicable)
    Notes
    [12] - Impossible to determine as 32 CRFs were not completed/available.
    [13] - Impossible to determine as 32 CRFs were not completed/available.
    [14] - Impossible to determine as 32 CRFs were not completed/available.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall Study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 Two groups of patients were included. All patients received ursodeoxycholic acid: active IBD group (20 individuals), IBD remission group (1 individual)

    Reporting group title
    No treatment arm
    Reporting group description
    		 No treatment arm contains the healthy volunteer group (26 individuals) and primary sclerosing cholangitis group (0 individuals).

    Reporting group title
    Unknown
    Reporting group description
    		 ICF IBD signed but no CRF completed and thus impossible to determine in which group the subjects were enrolled.

    Serious adverse events
    		 Treatment arm No treatment arm Unknown
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 26 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment arm No treatment arm Unknown
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 26 (0.00%)
    0 / 8 (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 non-serious adverse events were recorded for the participating patients

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Dec 2014
    Amendment to information of the CT application form, the protocol and the ICF form have been made due to a change in the quality of IMP and conduct or management of the trial. - Commercial investigational product was changed from Ursochol (150 mg tablets) to UrsoFalk (250 mg tablets). Active component remained the same. - An extra group of patients was added: a PSC group (=Patients with known primary sclerosing cholangitis).

    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.
    32 CRFs were not completed/available. No articles were published as no sufficient data was available.
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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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