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    Clinical Trial Results:
    Characterization of nerve-modulated macrophage population in the gastrointestinal tract

    Summary
    EudraCT number
    		 2018-002192-18
    Trial protocol
    		 BE  
    Global end of trial date
    19 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Sep 2025
    First version publication date
    10 Sep 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PrucaloprideRNAseq
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02425774
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 EC UZ Leuven S-number: S61248
    Sponsors
    Sponsor organisation name
    UZ Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Guy Boeckxstaens, KU Leuven, +32 16342883,
    Scientific contact
    Guy Boeckxstaens, KU Leuven, +32 16342883,
    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
    19 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Aug 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Characterization of the macrophage population subset that is modulated by enteric neurons
    Protection of trial subjects
    Day untill discharge: the study nurse was available to assess occurance of any adverse events. The CRF was closed 30 days after the last intake of the study medication in case no adverse events occurred.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jul 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: 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)
    4
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion: - Age > 18 - Surgical removal of small bowel or colon (due to carcinoma or divertrikels) Exclusion: - Adj. radiotherapy - Pronounced intra-abdominal inflammation - Allergy for serotonine medication - Active IBD - Child-Pugh C - Creatinine clearance <50mL/min/1.73m² - ASA-PS >3 - Uncontrolled diabetes (>200mg/dl)

    Period 1
    Period 1 title
    Overall baseline period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    The patients were randomized by Laboratory Wolfs and the blind was remained until the analysis was performed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prucalopride
    Arm description
    		 16h (1x 2mg) and 2h (1x2mg) before the operation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prucalopride succinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2mg, 16u voor de operatie 2mg, 2u voor de operatie De studie-verpleegkundige is aanwezig tijdens het innemen (voor compliance)

    Arm title
    		 Placebo
    Arm description
    		 1 tablet placebo 16h and 2h before the operation
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet 16u voor de operatie 1 tablet 2u voor de operatie

    Number of subjects in period 1
    		Prucalopride Placebo
    Started
    8
    8
    Completed
    8
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall baseline period
    Reporting group description
    		 -

    Reporting group values
    		 Overall baseline period 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)
    		 4 4
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Prucalopride
    Reporting group description
    		 16h (1x 2mg) and 2h (1x2mg) before the operation

    Reporting group title
    Placebo
    Reporting group description
    		 1 tablet placebo 16h and 2h before the operation

    Primary: Percentage of monocytes

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    End point title
    		 Percentage of monocytes
    End point description
    End point type
    Primary
    End point timeframe
    Single cell RNA sequencing was performed following the bowel resection.
    End point values
    		 Prucalopride Placebo
    Number of subjects analysed
    5 [1]
    7 [2]
    Units: percent
        arithmetic mean (standard deviation)
    13.99 ( 15.09 )
    13.91 ( 15.46 )
    Notes
    [1] - Some samples were excluded from the analysis due to bad sample quality.
    [2] - Some samples were excluded from the analysis due to bad sample quality.
    Statistical analysis title
    		 %monocytes in PRUC vs PLAC
    Comparison groups
    Prucalopride v Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Percentage of LYVE1+ macrophages

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    End point title
    		 Percentage of LYVE1+ macrophages
    End point description
    LYVE1 = Lymphatic Vessel Endothelial Hyaluronan Receptor 1 Top differentially expressed genes of this macrophage cluster shows that it matches with LYVE1+ macrophages previously described in literature.
    End point type
    Primary
    End point timeframe
    Single cell RNA sequencing was performed following the bowel resection.
    End point values
    		 Prucalopride Placebo
    Number of subjects analysed
    5 [3]
    7 [4]
    Units: percent
        arithmetic mean (standard deviation)
    32.85 ( 8.472 )
    35.25 ( 9.552 )
    Notes
    [3] - Some samples were excluded from the analysis due to bad sample quality.
    [4] - Some samples were excluded from the analysis due to bad sample quality.
    Statistical analysis title
    		 %LYVE+ Macs in PRUC vs PLAC
    Comparison groups
    Placebo v Prucalopride
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Percentage of APOE+ macrophages

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    End point title
    		 Percentage of APOE+ macrophages
    End point description
    APOE = apolipoprotein E
    End point type
    Primary
    End point timeframe
    Single cell RNA sequencing was performed following the bowel resection.
    End point values
    		 Prucalopride Placebo
    Number of subjects analysed
    5 [5]
    7 [6]
    Units: percent
        arithmetic mean (standard deviation)
    21.01 ( 15.06 )
    13.49 ( 4.786 )
    Notes
    [5] - Some samples were excluded from the analysis due to bad sample quality.
    [6] - Some samples were excluded from the analysis due to bad sample quality.
    Statistical analysis title
    		 APOE+ Macs in PRUC vs PLAC
    Comparison groups
    Prucalopride v Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Percentage of differentiating macrophages

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    End point title
    		 Percentage of differentiating macrophages
    End point description
    Top differentially expressed genes show this cluster has both monocyte and mature macrophage markers.
    End point type
    Primary
    End point timeframe
    Single cell RNA sequencing was performed following the bowel resection.
    End point values
    		 Prucalopride Placebo
    Number of subjects analysed
    5 [7]
    7 [8]
    Units: percent
        arithmetic mean (standard deviation)
    17.1 ( 3.449 )
    18.51 ( 6.869 )
    Notes
    [7] - Some samples were excluded from the analysis due to bad sample quality.
    [8] - Some samples were excluded from the analysis due to bad sample quality.
    Statistical analysis title
    		 % differentiating Macs in PRUC vs PLAC
    Comparison groups
    Prucalopride v Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Percentage of mitochondrial gene-enriched macrophages

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    End point title
    		 Percentage of mitochondrial gene-enriched macrophages
    End point description
    Top differentially expressed genes of this macrophage cluster are mitochondrial genes.
    End point type
    Primary
    End point timeframe
    Single cell RNA sequencing was performed following the bowel resection.
    End point values
    		 Prucalopride Placebo
    Number of subjects analysed
    5 [9]
    7 [10]
    Units: percent
        arithmetic mean (standard deviation)
    8.852 ( 6.087 )
    10.57 ( 7.537 )
    Notes
    [9] - Some samples were excluded from the analysis due to bad sample quality.
    [10] - Some samples were excluded from the analysis due to bad sample quality.
    Statistical analysis title
    		 % mitochondria enriched Macs in PRUC vs PLAC
    Comparison groups
    Prucalopride v Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Percentage of cytokine gene-enriched macrophages

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    End point title
    		 Percentage of cytokine gene-enriched macrophages
    End point description
    Top differentially expressed genes of this macrophage cluster are pro-inflammatory cytokine genes.
    End point type
    Primary
    End point timeframe
    Single cell RNA sequencing was performed following the bowel resection.
    End point values
    		 Prucalopride Placebo
    Number of subjects analysed
    5 [11]
    7 [12]
    Units: percent
        arithmetic mean (standard deviation)
    3.753 ( 1.379 )
    5.234 ( 1.788 )
    Notes
    [11] - Some samples were excluded from the analysis due to bad sample quality.
    [12] - Some samples were excluded from the analysis due to bad sample quality.
    Statistical analysis title
    		 % Cytokine-rich Macs in PRUC vs PLAC
    Comparison groups
    Prucalopride v Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Percentage of LYVE1+ macrophages (cluster 2)

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    End point title
    		 Percentage of LYVE1+ macrophages (cluster 2)
    End point description
    LYVE1 = Lymphatic Vessel Endothelial Hyaluronan Receptor 1 Top differentially expressed genes of this second LYVE1+ macrophage cluster shows high similarity to LYVE1+ macrophages previously described in literature.
    End point type
    Primary
    End point timeframe
    Single cell RNA sequencing was performed following the bowel resection.
    End point values
    		 Prucalopride Placebo
    Number of subjects analysed
    5 [13]
    7 [14]
    Units: percent
        arithmetic mean (standard deviation)
    2.452 ( 1.328 )
    3.048 ( 3.367 )
    Notes
    [13] - Some samples were excluded from the analysis due to bad sample quality.
    [14] - Some samples were excluded from the analysis due to bad sample quality.
    Statistical analysis title
    		 %LYVE+ Macs (2) in PRUC vs PLAC
    Comparison groups
    Prucalopride v Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs, SAEs, and AESIs: until 30 days after the last treatment administration or until the last follow-up visit (whichever is later). All SAEs and AESIs: must be reported to the Sponsor within 24 hours of the event becoming known to trial personnel.
    Adverse event reporting additional description
    Since our IMP has a European license, we will not report any adverse events listed in the SmPC. The patient will be followed up from the time they take the first placebo/prucalopride tablet until their discharge.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 No dictionary used
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Prucalopride
    Reporting group description
    		 16h (1x 2mg) and 2h (1x2mg) before the operation

    Reporting group title
    Placebo
    Reporting group description
    		 1 tablet placebo 16h and 2h before the operation

    Serious adverse events
    		 Prucalopride Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Gastrointestinal perforation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroparesis postoperative
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    		 Prucalopride Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    5 / 8 (62.50%)
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Hypotension
         subjects affected / exposed
    2 / 8 (25.00%)
    3 / 8 (37.50%)
         occurrences all number
    2
    3
    Tachycardia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0
    Gastrointestinal disorders
    Epigastric discomfort
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    C-reactive protein increased
    Additional description: CRP increase without clinical focus
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 8 (25.00%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jul 2019
    Uitbereiding met 10 patiënten die een dundarmresectie ondergaan + uitbereiding beleid over data handling, data management en vertrouwelijkheid van gegevens.
    04 Jul 2020
    Datum!!!! Uitbereiding experimenten met NMT-seq. aanpassing naar 6 patiënten per groep en toevoeging van bloedstaal voor testing Covid-antilichamen.

    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
    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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