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    Clinical Trial Results:
    Multicentric, double-blind, placebo controlled clinical trial with 5-hydroxytryptophan (5-HTP) in patients with inflammatory bowel disease in clinical and biologic remission: effect on fatigue scores

    Summary
    EudraCT number
    		 2017-005059-10
    Trial protocol
    		 BE  
    Global end of trial date
    03 Mar 2021

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

    Trial information

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    Trial identification
    Sponsor protocol code
    Trp-IBD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03574948
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital of Ghent
    Sponsor organisation address
    C. Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Bimetra Clinics, Ghent University Hospital, +32 9332 0500, anneleen.peeters@uzgent.be
    Scientific contact
    Bimetra Clinics, Ghent University Hospital, 093321073 9332 0500, anneleen.peeters@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
    06 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the effect of oral 5-HTP on the global fatigue score self-reported by patient (VAS)
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 The subject is treated with biologicals and/or immunosuppressiva since at least 6 months with stable dose over last 3 months
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2018
    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
    Belgium: 166
    Worldwide total number of subjects
    166
    EEA total number of subjects
    166
    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)
    166
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrollment occurred between December 2018 and November 2020 at 13 sites across Belgium

    Pre-assignment
    Screening details
    		 The subject is male or female and aged 18 to 60 yrs (inclusive), has CD or CU, is in clinical remission at day 0 based on validated scores (SCCAI ≤ 2 for CU or Harvey Bradshaw index ≤ 4 for CD), reports fatigue on a quantified scale (visual analogue scale 0 – 10) of 5 or more, treated with biologicals and/or immunosuppressiva since at least 6 month

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Subjects, researchers & statisticians were blinded to allocation to Investigational Medicinal Product (IMP). Placebo and active medication comparator were designed and manufactured to be visually indistinguishable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 5-HTP first then placebo
    Arm description
    		 Subjects were randomised to 5-HTP for the first 8 weeks and Placebo in the following 8 weeks in a cross over study.
    Arm type
    		 experimental and placebo

    Investigational medicinal product name
    5-HTP
    Investigational medicinal product code
    Other name
    L-5-hydroxytryptophan (5-HTP) (Levotonine R)
    Pharmaceutical forms
    Pillules
    Routes of administration
    Oral use
    Dosage and administration details
    100MG twice daily for the first 8 weeks

    Investigational medicinal product name
    placebo for 5-HTP
    Investigational medicinal product code
    Other name
    Lactose monohydrate 100 mg
    Pharmaceutical forms
    Pillules
    Routes of administration
    Oral use
    Dosage and administration details
    100mg twice daily dor the following 8 weeks

    Arm title
    		 placebo first, then 5HTP
    Arm description
    		 Subjects were randomised to placebo for the first 8 weeks and 5-HTP in the following 8 weeks in a cross over study.
    Arm type
    		 experimental and placebo

    Investigational medicinal product name
    5-HTP
    Investigational medicinal product code
    Other name
    L-5-hydroxytryptophan (5-HTP) (Levotonine R)
    Pharmaceutical forms
    Pillules
    Routes of administration
    Oral use
    Dosage and administration details
    100MG twice daily for the following 8 weeks in cross over study

    Investigational medicinal product name
    placebo for 5-HTP
    Investigational medicinal product code
    Other name
    Lactose monohydrate 100 mg
    Pharmaceutical forms
    Pillules
    Routes of administration
    Oral use
    Dosage and administration details
    100mg twice daily for the first 8 weeks

    Number of subjects in period 1
    		5-HTP first then placebo placebo first, then 5HTP
    Started
    82
    84
    period 1
    82
    84
    Period 2
    78
    78
    Completed
    75
    74
    Not completed
    7
    10
         drug toxicity
    2
    4
         patient's wish
    -
    4
         patient wish
    3
    -
         poor compliance
    1
    2
         no longer meets study criteria
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    5-HTP first then placebo
    Reporting group description
    		 Subjects were randomised to 5-HTP for the first 8 weeks and Placebo in the following 8 weeks in a cross over study.

    Reporting group title
    placebo first, then 5HTP
    Reporting group description
    		 Subjects were randomised to placebo for the first 8 weeks and 5-HTP in the following 8 weeks in a cross over study.

    Reporting group values
    		 5-HTP first then placebo placebo first, then 5HTP Total
    Number of subjects
    		 82 84 166
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 38.5 (29.8 to 45.0) 39.0 (29.3 to 48.0) -
    Gender categorical
    Units: Subjects
        Female
    		 45 49 94
        Male
    		 37 35 72

    End points

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    End points reporting groups
    Reporting group title
    5-HTP first then placebo
    Reporting group description
    		 Subjects were randomised to 5-HTP for the first 8 weeks and Placebo in the following 8 weeks in a cross over study.

    Reporting group title
    placebo first, then 5HTP
    Reporting group description
    		 Subjects were randomised to placebo for the first 8 weeks and 5-HTP in the following 8 weeks in a cross over study.

    Subject analysis set title
    after 5-HTP treatment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    subject analysis set after 8 weeks of 5-HTP

    Subject analysis set title
    after placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    subject analysis set after 8 weeks of placebo

    Primary: Percentage of patients reaching >=20% reduction in fVAS

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    End point title
    		 Percentage of patients reaching >=20% reduction in fVAS
    End point description
    End point type
    Primary
    End point timeframe
    At end of Treatment Periods 1 and 2
    End point values
    		 after 5-HTP treatment after placebo
    Number of subjects analysed
    149
    149
    Units: patients
    53
    56
    Statistical analysis title
    		 McNemar’s test
    Comparison groups
    after placebo v after 5-HTP treatment
    Number of subjects included in analysis
    298
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.83
    Method
    		 Mcnemar
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were reported from the first drug administration until the end of study (week 16)
    Adverse event reporting additional description
    AEs were assessed at each study visit and were defined as serious if they resulted in death (or were life-threatening), required hospitalization, or resulted in significant disability.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    gastrointestinal
    Reporting group description
    		 -

    Reporting group title
    surgical and medical procedures
    Reporting group description
    		 -

    Serious adverse events
    		 gastrointestinal surgical and medical procedures
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 161 (0.62%)
    2 / 161 (1.24%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Hospitalisation for polysomnography
    Additional description: Hospitalisation for polysomnography
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 161
    0 / 161
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    knee replacement
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 161
    0 / 161
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Abdominal pain and diarhea requiring hospitalisation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 gastrointestinal surgical and medical procedures
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 161 (11.18%)
    0 / 161 (0.00%)
    Gastrointestinal disorders
    gastrointestinal
         subjects affected / exposed
    18 / 161 (11.18%)
    0 / 161 (0.00%)
         occurrences all number
    18
    0

    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.
    Mainly patients with Crohn’s disease were included

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35940251
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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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