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    Clinical Trial Results:
    The prevalence of bile acid diarrhéa and the effect of budesonid on the bile acid homeostasis in patients with microscopic colitis

    Summary
    EudraCT number
    		 2019-002762-12
    Trial protocol
    		 DK  
    Global end of trial date
    23 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Dec 2024
    First version publication date
    04 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SJ-674
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    Lykkebaekvej 1, Koege, Denmark, 4600
    Public contact
    Department of Medicine, Zealand University Hospital, rubenlorentsen@hotmail.com
    Scientific contact
    Department of Medicine, Zealand University Hospital, rubenlorentsen@hotmail.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
    07 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the prevalence of bile acid diarrhea (BAD) in patients with active microscopic colitis (MC). The apperance of BAD is defined by watery stools and a raised level of 7alpha-hydroxy-4-cholesten-3-on (C4).
    Protection of trial subjects
    Patients with flare in microscopic colitis were included and we studied the bile acid homeostasis alongside standard treatment with budesonide. If patients after end oftreatment had relapse in diarrhoea, treatment was initiated by the local responsible phycisian
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 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
    Denmark: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    30
    From 65 to 84 years
    29
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with suspected active diarrhea due to microscopic colitis were included. During the baseline periode, we screened away patients who did not have diarrhea by objective measure (diary recirdings)

    Pre-assignment
    Screening details
    		 We pre-screened 134 patient charts for possible inclusion. 31 did not meeyt inclusion cretiera, 11 met exclusion criteria, 28 declined participation on first contact, 6 were already started on treatment (exlusion criterion), 1 had too old a colonoscopy diagnostic of MC. 60 were eligible for baseline screenining

    Period 1
    Period 1 title
    Baseline screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 No Rx
    Arm description
    		 No treatment given, the system does not allow a baseline periode without treamtnet. Info added to circumvent hardstop
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide
    Investigational medicinal product code
    Other name
    EntoCort
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment not started during baseline. 3 tablets of 3 mg each (total 9mg) each morning for 6 weeks

    Number of subjects in period 1
    		No Rx
    Started
    60
    Completed
    49
    Not completed
    11
         Consent withdrawn by subject
    7
         No diarrhea
    4
    Period 2
    Period 2 title
    Budesonide treatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Budesonide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide
    Investigational medicinal product code
    Other name
    EntoCort
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3 tablets of 3 mg each (total 9mg) each morning for 6 weeks

    Number of subjects in period 2
    		Budesonide
    Started
    49
    Completed
    49
    Period 3
    Period 3 title
    After treatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 No Rx
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		No Rx
    Started
    49
    Completed
    49

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    No Rx
    Reporting group description
    		 No treatment given, the system does not allow a baseline periode without treamtnet. Info added to circumvent hardstop
    Reporting group title
    Budesonide
    Reporting group description
    		 -
    Reporting group title
    No Rx
    Reporting group description
    		 -

    Subject analysis set title
    Primary endpoint
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients who started treatment

    Primary: Co-existing bile acid diarrhea

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    End point title
    		 Co-existing bile acid diarrhea [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline C4
    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 end point was the prevalence of co-existing bile acid diarrhea in patients with flare in microscopic colitis. This system only allows creation of statistital analyses with a comparator/control group, however, the needed analysis (Wilson's CI of binary data) does not have a control group. 6 (12%) of 49 patients (95%CI 5-25%) had co-existing bile acid diarrhea
    End point values
    		 Budesonide
    Number of subjects analysed
    49
    Units: Bile acid diarrhea
        MC and BAD
    6
        MC no BAD
    43
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From treatment start (period2) until end of the 'after treatment' period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    20240925
    Reporting groups
    Reporting group title
    AE reporting
    Reporting group description
    		 -

    Serious adverse events
    		 AE reporting
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 49 (4.08%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer metastatic
    Additional description: SCTID: 254837009. Patient with prior breast cancer. During follow-up a recurrence in an axillary lymph node is discovered
         subjects affected / exposed
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Migraine without aura
    Additional description: SCTID: 425007008
         subjects affected / exposed
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 AE reporting
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 49 (8.16%)
    Respiratory, thoracic and mediastinal disorders
    Rhinitis
    Additional description: SCTID: 254837009
         subjects affected / exposed
    4 / 49 (8.16%)
         occurrences all number
    4

    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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    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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