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    Clinical Trial Results:
    The role of mast cells on duodenal permeability after duodenal acid perfusion in healthy volunteers

    Summary
    EudraCT number
    		 2015-000244-42
    Trial protocol
    		 BE  
    Global end of trial date
    13 Dec 2016

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

    Trial information

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    Trial identification
    Sponsor protocol code
    acid_permeability_healthyvolunteers
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZLeuven / KULeuven / TARGID
    Sponsor organisation address
    herestraat 49, Leuven, Belgium, 3000
    Public contact
    Jan Tack, UZLeuven / KULeuven / TARGID, jan.tack@kuleuven.be
    Scientific contact
    Jan Tack, UZLeuven / KULeuven / TARGID, jan.tack@kuleuven.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
    13 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of mast cell inhibition on duodenal mucosal integrity of healthy volunteers after acid infusion in the duodenum
    Protection of trial subjects
    healthy volunteers
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 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
    Belgium: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy volunteers were recruited from a mailing list

    Pre-assignment
    Screening details
    		 exclusion of gastrointestinal symptoms no history of gastrointestinal disease no regular use of medication besides oral contraceptives, no type 1 or 2 diabetes no first-degree family members with type 1 diabetes, celiac disease or inflammatory bowel disease no first-degree family members with type 1 diabetes, celiac disease or IBD

    Period 1
    Period 1 title
    2 week mast cell stabilization or plac
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 disodiumcromoglycate
    Arm description
    		 intake of disodiumcromoglycate (DSCG; Nalcrom, Italchimici SpA, Rome, Italy), a mast cell stabilizer, 200 mg qid for 2 weeks before the acid perfusion study
    Arm type
    		 Experimental

    Investigational medicinal product name
    disodiumcromoglycate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    intake of oral disodiumcromoglycate (DSCG; Nalcrom, Italchimici SpA, Rome, Italy), a mast cell stabilizer, 200 mg qid for 2 weeks before study day with acid perfusion study

    Arm title
    		 placebo
    Arm description
    		 intake of oral placebo (190 mg mannitol) qid during 2 weeks before the acid perfusion study
    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
    Oral intake of placebo capsule (190 mg mannitol) qid for 2 weeks before the acid perfusion study day

    Number of subjects in period 1
    		disodiumcromoglycate placebo
    Started
    10
    10
    Completed
    10
    10
    Period 2
    Period 2 title
    part 1 saline/acid perfusion
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 saline
    Arm description
    		 Afer a stabilization period of 20 min, one investigator started the infusion of saline in the duodenum at a rate of 5 mL min−1 during 30 min, in a randomized, cross-over manner
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    an assembly including a pH electrode with an antimony pH sensor and a thin infusion tube (2 mm diameter) was introduced transnasally and positioned in the second portion of the duodenum afer an overnight fast. Infusion of saline in the duodenum at a rate of 5 mL min−1 during 30 min

    Arm title
    		 acid infusion
    Arm description
    		 Afer a stabilization period of 20 min, one investigator started the infusion of f 0.1 N HCl (acid) in the duodenum at a rate of 5 mL min−1 during 30 min, in a randomized, cross-over manner
    Arm type
    		 Active comparator

    Investigational medicinal product name
    0.1 N HCl (acid)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Other use
    Dosage and administration details
    an assembly including a pH electrode with an antimony pH sensor and a thin infusion tube (2 mm diameter) was introduced transnasally and positioned in the second portion of the duodenum afer an overnight fast. Infusion of 0.1 N HCl (acid) in the duodenum at a rate of 5 mL min−1 during 30 min

    Number of subjects in period 2
    		saline acid infusion
    Started
    10
    10
    Completed
    10
    10
    Period 3
    Period 3 title
    overal trial
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst

    Arms
    Arm title
    		 overal trial
    Arm description
    		 -
    Arm type
    		 overal trial subjects

    Investigational medicinal product name
    disodiumcromoglycate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    intake of oral disodiumcromoglycate (DSCG; Nalcrom, Italchimici SpA, Rome, Italy), a mast cell stabilizer, 200 mg qid for 2 weeks before study day with acid perfusion study

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral intake of placebo capsule (190 mg mannitol) qid for 2 weeks before the acid perfusion study day

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    an assembly including a pH electrode with an antimony pH sensor and a thin infusion tube (2 mm diameter) was introduced transnasally and positioned in the second portion of the duodenum afer an overnight fast. Infusion of saline in the duodenum at a rate of 5 mL min−1 during 30 min

    Investigational medicinal product name
    0.1 N HCl (acid)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Other use
    Dosage and administration details
    an assembly including a pH electrode with an antimony pH sensor and a thin infusion tube (2 mm diameter) was introduced transnasally and positioned in the second portion of the duodenum afer an overnight fast. Infusion of 0.1 N HCl (acid) in the duodenum at a rate of 5 mL min−1 during 30 min

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The study was divided into 2 parts with each 10 healthy volunteers. In total there were 20 participants. Period 3 was made as the overall study to be able to set the baseline characteristics of all 20 participants together.
    Number of subjects in period 3
    		overal trial
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overal trial
    Reporting group description
    		 full group: part 1 + part 2

    Reporting group values
    		 overal trial Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.9 ( 8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    disodiumcromoglycate
    Reporting group description
    		 intake of disodiumcromoglycate (DSCG; Nalcrom, Italchimici SpA, Rome, Italy), a mast cell stabilizer, 200 mg qid for 2 weeks before the acid perfusion study

    Reporting group title
    placebo
    Reporting group description
    		 intake of oral placebo (190 mg mannitol) qid during 2 weeks before the acid perfusion study
    Reporting group title
    saline
    Reporting group description
    		 Afer a stabilization period of 20 min, one investigator started the infusion of saline in the duodenum at a rate of 5 mL min−1 during 30 min, in a randomized, cross-over manner

    Reporting group title
    acid infusion
    Reporting group description
    		 Afer a stabilization period of 20 min, one investigator started the infusion of f 0.1 N HCl (acid) in the duodenum at a rate of 5 mL min−1 during 30 min, in a randomized, cross-over manner
    Reporting group title
    overal trial
    Reporting group description
    		 -

    Primary: Intragastric pressure

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    End point title
    		 Intragastric pressure
    End point description
    End point type
    Primary
    End point timeframe
    A high-resolution manometry (HRM) catheter was inserted . After a stabilization period of 20 min, infusion of 0.1 N HCl (acid) or saline was started in the duodenum at a rate of 5 mL min−1 during 30 min, in a randomized, cross-over manner.
    End point values
    		 disodiumcromoglycate placebo saline acid infusion
    Number of subjects analysed
    10
    10
    10
    10
    Units: mmHg
        least squares mean (standard deviation)
    -39.8 ( 17.8 )
    -36.7 ( 9.1 )
    9.6 ( 8.1 )
    -52.4 ( 13.2 )
    Statistical analysis title
    		 IGP infusion vs saline
    Comparison groups
    saline v acid infusion
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 t-test, 1-sided
    Confidence interval

    Primary: Intragastric pressure

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    End point title
    		 Intragastric pressure
    End point description
    End point type
    Primary
    End point timeframe
    a high-resolution manometry (HRM) catheter ) was inserted through the nose and positioned in the gastric fundus. Afer a stabilization period of 20 min infusion of 0.1 N HCl (acid) or saline in the duodenum at a rate of 5 mL min−1 during 30 min.
    End point values
    		 disodiumcromoglycate placebo
    Number of subjects analysed
    10
    10
    Units: mmHg
        median (standard deviation)
    -39.8 ( 17.8 )
    -36.7 ( 9.1 )
    Statistical analysis title
    		 intragastric pressure
    Comparison groups
    placebo v disodiumcromoglycate
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.86
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For each individual, corresponds to timeframe of study participation (from signing of informed consent until last visit).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: there were no AE during this trial

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33060783
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