Clinical Trial Results:
Effect of Proton Pump Inhibitors on the duodenal microbiome in healthy volunteers
Summary
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EudraCT number |
2017-004248-39 |
Trial protocol |
BE |
Global end of trial date |
22 Sep 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Dec 2020
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First version publication date |
05 Dec 2020
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Other versions |
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Summary report(s) |
Summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PPI-microbiome
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03545243 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
KU Leuven
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Sponsor organisation address |
Herestraat, 49, Leuven, Belgium, 3000
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Public contact |
TARGID, TARGID, KU Leuven, +32 16372093, lucas.wauters@kuleuven.be
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Scientific contact |
TARGID, TARGID, KU Leuven, 0484119682 16372093, lucas.wauters@kuleuven.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
22 Sep 2020
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Sep 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the effect of Proton Pump Inhibitors (PPI) on the duodenal, oral and fecal microbiota composition in healthy volunteers
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Protection of trial subjects |
local and optional IV sedation with endoscopy
local sedation and radioprotection with nasoduodenal tube
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
30
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
All data were collected at KU Leuven and University Hospitals Leuven (Leuven, Belgium) between April 2018 - April 2020 | ||||||
Pre-assignment
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Screening details |
All subjects were female or male, aged 18 to 64 years old, with no active psychiatric, atopic, inflammatory or metabolic conditions. | ||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
open
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Arms
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Arm title
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Healthy volunteers | ||||||
Arm description |
Study procedures were performed before and after (1) start PPI-therapy (pantoprazole 40mg OD for 4 weeks) | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Pantomed
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Investigational medicinal product code |
A02BC02
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Other name |
pantoprazole
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
40mg once daily for 4 weeks
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Healthy volunteers
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Reporting group description |
Study procedures were performed before and after (1) start PPI-therapy (pantoprazole 40mg OD for 4 weeks) |
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End point title |
duodenal eosinophils [1] | ||||||||
End point description |
duodenal eosinophil counts
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End point type |
Primary
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End point timeframe |
overall trial
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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: Please refer to Charts for statistical data section regarding within-group analysis |
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Attachments |
HV |
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No statistical analyses for this end point |
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End point title |
Symptoms | ||||||||
End point description |
0
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End point type |
Secondary
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End point timeframe |
overall trial
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Attachments |
HV |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
overall trial
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Adverse event reporting additional description |
0
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
4
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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: no serious adverse event was observed with pantomed in healthy volunteers |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
NA |