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    Clinical Trial Results:
    A Phase 1 randomised, double-blind, placebo-controlled study to assess the safety and tolerability of Bacteroides thetaiotaomicron in young people aged 16 to 18 years with stable Crohn's disease.

    Summary
    EudraCT number
    		 2014-005666-29
    Trial protocol
    		 GB  
    Global end of trial date
    10 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Nov 2018
    First version publication date
    01 Nov 2018
    Other versions
    Summary report(s)
    		 Theta-001-synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    Theta 001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02704728
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    4D Pharma Research Ltd
    Sponsor organisation address
    9 Bond Court, Leeds, United Kingdom, LS1 2JZ
    Public contact
    Chief Medical Officer, 4D Pharma Plc, +44 113 895 0130, john.weinberg@4dpharmaplc.com
    Scientific contact
    Chief Medical Officer, 4D Pharma Plc, +44 113 895 0130, john.weinberg@4dpharmaplc.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
    31 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the tolerability and safety of B. theta when administered as a single dose and in multiple doses.
    Protection of trial subjects
    This was a first in man safety study. Individual subject stopping rules were defined in the protocol relating to exacerbation of Crohn’s disease and systemic infection. Subjects were asked to record their body temperature twice daily at home and to contact the hospital/study team in the event of a fever.
    Background therapy
    		 None
    Evidence for comparator
    		 Placebo comparator randomized 4: active:placebo
    Actual start date of recruitment
    05 Oct 2015
    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
    United Kingdom: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    15
    Adults (18-64 years)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 D-28: screening visit: check of subject’s ability and willingness to swallow 3× size 0 placebo capsules D-3 - D0: 2 stool samples requested

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo single dose
    Arm description
    		 Placebo single dose (single dose consisting of 3 capsules)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Off white intrinsically enteric size 0 capsules containing microcrystalline cellulose.

    Arm title
    		 Thetanix Single dose
    Arm description
    		 Experimental single dose (single dose consisting of 3 capsules)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Thetanix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Off white intrinsically enteric size 0 capsules containing lyophilised B. thetaiotaomicron. Each capsule contains 10^7.73±1.43 colony forming units (CFUs) and microcrystalline cellulose.

    Arm title
    		 Placebo multiple doses
    Arm description
    		 Placebo multiple doses (twice daily dosing period of 7.5 days)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Off white intrinsically enteric size 0 capsules containing microcrystalline cellulose.

    Arm title
    		 Thetanix multiple doses
    Arm description
    		 Experimental multiple doses (twice daily dosing period of 7.5 days)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Thetanix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Off white intrinsically enteric size 0 capsules containing lyophilised B. thetaiotaomicron. Each capsule contains 10^7.73±1.43 colony forming units (CFUs) and microcrystalline cellulose.

    Number of subjects in period 1
    		Placebo single dose Thetanix Single dose Placebo multiple doses Thetanix multiple doses
    Started
    2
    6
    2
    8
    Completed
    2
    6
    2
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Single Period
    Reporting group description
    		 -

    Reporting group values
    		 Single Period Total
    Number of subjects
    		 18 18
    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)
    		 15 15
        Adults (18-64 years)
    		 3 3
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 16.75 ( 0.886 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    Placebo single dose
    Reporting group description
    		 Placebo single dose (single dose consisting of 3 capsules)

    Reporting group title
    Thetanix Single dose
    Reporting group description
    		 Experimental single dose (single dose consisting of 3 capsules)

    Reporting group title
    Placebo multiple doses
    Reporting group description
    		 Placebo multiple doses (twice daily dosing period of 7.5 days)

    Reporting group title
    Thetanix multiple doses
    Reporting group description
    		 Experimental multiple doses (twice daily dosing period of 7.5 days)

    Primary: Adverse events

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    End point title
    		 Adverse events [1]
    End point description
    All AEs were coded by the MedDRA.
    End point type
    Primary
    End point timeframe
    by study completion
    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 were performed for this study due to the small sample size which would give erroneous results
    End point values
    		 Placebo single dose Thetanix Single dose Placebo multiple doses Thetanix multiple doses
    Number of subjects analysed
    2
    6
    2
    8
    Units: Adverse Events
    2
    6
    2
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Single dose: Pre-dose/ 2, 4, 8h post inpatient dose/ 24 h post-dose/ Day 7 Multiple dose: Pre-dose/ 2,4 h post first inpatient dose/ 24h post first dose/ pre-, 2, 4h post last dose/ day 14/ day 56 Completion of a diary card. AE followed to resolution
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Placebo (Part A)
    Reporting group description
    		 single oral dose (a dose consisted of 3 capsules)

    Reporting group title
    Thetanix single dose (Part A)
    Reporting group description
    		 single oral dose (a dose consisted of 3 capsules)

    Reporting group title
    Placebo (Part B)
    Reporting group description
    		 -

    Reporting group title
    Thetanix multiple dose (Part B)
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo (Part A) Thetanix single dose (Part A) Placebo (Part B) Thetanix multiple dose (Part B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo (Part A) Thetanix single dose (Part A) Placebo (Part B) Thetanix multiple dose (Part B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    4 / 8 (50.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    1
    Dizziness
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    1
    0
    2
    Eructation
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrooesophageal reflux
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Mar 2016
    Temporary halt (delay in the start of dosing)
    09 May 2016
    Reinitiation of the clinical trial following the Temporary Halt
    09 May 2016
    Placebo shelf life extension
    16 Sep 2016
    Change in Drug Product Shelf-life (Revision of the method of determination)
    20 Dec 2016
    New protocol version
    15 May 2017
    Manufacturing Process Changes
    14 Jul 2017
    New protocol version

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Mar 2016
    Delay in the start of dosing for the study due to supply issues
    26 May 2016

    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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