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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
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
|
|
||||||||||
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
|
|||||||||
|
||||||||||
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
|
|||||||||
|
||||||||||
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. |
||||||||||
|
|
|||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||
Reporting group title |
overal trial
|
||||||||||||||||||||||||||||||||||||
Reporting group description |
full group: part 1 + part 2 | ||||||||||||||||||||||||||||||||||||
|
|
|||
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 |
- |
|
|||||||||||||||||||||
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.
|
||||||||||||||||||||
|
|||||||||||||||||||||
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 |
|
|||||||||||||
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.
|
||||||||||||
|
|||||||||||||
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 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 |
|
|||
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 |