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    Clinical Trial Results:
    Rifaximin-treatment of Collagenous colitis: A prospective, double-blind, placebo-controlled study

    Summary
    EudraCT number
    		 2018-001891-39
    Trial protocol
    		 DK  
    Global end of trial date
    01 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2022
    First version publication date
    15 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    version4.6,29082018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03658993
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sabine Becker, Senior Physician Clinic of Gastrointestinal- and Infectious Diseases, Diagnostic Center Silkeborg Regional Hospital,
    Sponsor organisation address
    Falkevej 1-3,, Silkeborg, Denmark, 8600
    Public contact
    XiCoCo study group, sabbec@rm.dk, XiCoCo study group, sabbec@rm.dk, sabbec@rm.dk
    Scientific contact
    XiCoCo study group, sabbec@rm.dk, XiCoCo study group, sabbec@rm.dk, sabbec@rm.dk
    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
    16 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The aim of this study is to assess if 4 weeks treatment with Rifaximin as a supplement to a standard course of Budesonide against active Collagenous Colitis can reduce the risk of relapse after treatment cessation.
    Protection of trial subjects
    All procedures were standard procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 The hypothesis of this study is that an altered gut microbiota is a contributory factor in initiating an inflammatory proces in the colonic mucosa leading to CC. We suggest that treatment with Budesonide reduces the inflammation without treating the underlying cause. In this trial we will try to remodellate gut microbiota by adding Rifaximin and and see whether we can reduce the risk of relapse after Budesonide-cessation.
    Actual start date of recruitment
    03 Sep 2018
    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
    Denmark: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    11
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with biopsy-verified CC and active disease. Patients were invited to participate in the study independently of age and disease duration.

    Pre-assignment
    Screening details
    		 Patients with known and new diagnosed collagenous colitis was considered for participation in the study. 39 pt were screened. 14 patients did not fulfil inclusion criteria and were excluded. 25 patients were included in the study and 16 patients fulfil the criteria for randomisation.

    Pre-assignment period milestones
    Number of subjects started
    		 39 [1]
    Number of subjects completed
    		 16

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 23
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: This is a single center study
    Period 1
    Period 1 title
    Randomised (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer
    Blinding implementation details
    Computer-generated block randomisation was performed by local pharmacy in blocks of eight. Study drug and placebo were packed and provided by Norgine. Data analysis was performed before treatment-group allocation was disclosed

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rifaxamine
    Arm description
    		 Patients in clinical remission after 4 weeks of open-label budesonide-therapy will randomly be assigned to receive oral rifaximin 550 mg TID for 4 weeks . Study drugs were commenced during budesonide treatment and continued 2 weeks after cessation of budesonide treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rifaxamine
    Investigational medicinal product code
    A07AA11
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    oral rifaximin 550 mg TID for 4 weeks

    Arm title
    		 placeboo
    Arm description
    		 Patients in clinical remission after 4 weeks of open-label budesonide-therapy will randomly be assigned to receive either: oral placebo TID for 4 weeks. Study drugs were commenced during budesonide treatment and continued 2 weeks after cessation of budesonide treatment.
    Arm type
    		 placebo

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Rifaxamine placeboo
    Started
    8
    8
    Completed
    7
    8
    Not completed
    1
    0
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomised
    Reporting group description
    		 -

    Reporting group values
    		 Randomised Total
    Number of subjects
    		 16 16
    Age categorical
    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)
    		 11 11
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Rifaxamine
    Reporting group description
    		 Patients in clinical remission after 4 weeks of open-label budesonide-therapy will randomly be assigned to receive oral rifaximin 550 mg TID for 4 weeks . Study drugs were commenced during budesonide treatment and continued 2 weeks after cessation of budesonide treatment.

    Reporting group title
    placeboo
    Reporting group description
    		 Patients in clinical remission after 4 weeks of open-label budesonide-therapy will randomly be assigned to receive either: oral placebo TID for 4 weeks. Study drugs were commenced during budesonide treatment and continued 2 weeks after cessation of budesonide treatment.

    Primary: Clinical remission

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    End point title
    		 Clinical remission
    End point description
    Remission defined as < 3 daily bowel movements or < 1 watery stool per day measured as a mean during the last week.
    End point type
    Primary
    End point timeframe
    Number of patients in clinical remission 12 weeks after cessation of Budesonide in the Rifaximin group compared to the placebo group.
    End point values
    		 Rifaxamine placeboo
    Number of subjects analysed
    7 [1]
    8
    Units: subjects
    7
    8
    Notes
    [1] - One patient was excluded because of protokolviolation
    Statistical analysis title
    		 Final- clinical data
    Comparison groups
    Rifaxamine v placeboo
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.05 [3]
    Method
    		 Logrank
    Parameter type
    		 Median difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [2] - All statistical tests were two-sided with the level of statistical significance set at P-value < 0.05
    [3] - All statistical tests were two-sided with the level of statistical significance set at P-value < 0.05

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse effect were reported at each control-visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    2022-08-31
    Reporting groups
    Reporting group title
    Rifaxamine group
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Rifaxamine group placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (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: 1%
    Non-serious adverse events
    		 Rifaxamine group placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 8 (25.00%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Pain
    Additional description: Muscular pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    Infections and infestations
    Herpes dermatitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         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
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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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