To ex vivo assess the difference in effect of administration of NSAIDs, PPISs and SSRIs on the paracellular permeability of colon biopsies (i.e. change in trans-epithelial electrical resistance) between active, remission and non-MC patients, using…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is the difference in colon permeability
(transpeithelial electrical resistance and FITC-permeation) caused by
administration of risk medication between the three groups (MC active, MC
remission, MC control)
Secondary outcome
n.a.
Background summary
Over the years several risk factors have been identified for MC. Medication
use, especially NSAIDs, PPIs, and SSRIs, prior to diagnosis is considered a
risk factor for MC development. However, the exact pathophysiological mechanism
is unclear. It is hypothesized that NSAIDs, PPIs, and SSRIs may have an effect
on the colon permeability, due to an idiosyncratic reaction which results in a
local immune response. MC patients are considered to be susceptible hosts,
prone to react on administration of abovementioned drugs. In order to test this
hypothesis and to generate new insights in the pathophysiology of MC, we want
to perform an Ussing chamber experiment using colon tissue samples, collected
within the framework of the cohort study.
Study objective
To ex vivo assess the difference in effect of administration of NSAIDs, PPISs
and SSRIs on the paracellular permeability of colon biopsies (i.e. change in
trans-epithelial electrical resistance) between active, remission and non-MC
patients, using the Ussing chamber system
Study design
case-control substudy
Study burden and risks
There is a 0.2% chance that a bleeding might occur, which can be stopped during
the same procedure or during a new colonscopy. Moreover, there is a very small
risk (<0.1%) of a bowel perforation. In case of a colonoscopy scheduled for
regular care, the study risk concerns the sampling of additional colon
biopsies. In theory, this may increase the chance of a procedure related
complication. Excact numbers, however, are not available. If an additional
endoscopic procedure has to be scheduled the burden increases due to the extra
procedure and the related hospital visit. To reduce the burden for the patient,
a sigmoidoscopy instead of a full colonoscopy will be performed. This is less
invasive, takes less time and will be less a burden to the patient. The bowel
preparation however, will remain the same, because of the potential influence
of bowel preparations of the colon barrier integrity (a differen bowel prep may
compromise study results).
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
In general: aged between 50-75 years, no current use of NSAIDs, PPIs or SSRIs.
* For patients in remission: positive diagnosis of microscopic, in remission under medication
* For patients with active disease: positive diagnosis of microscopic, collagenous or lymphocytic colitis; confirmed active disease due to relapse, no recent treatment for MC
* For healthy controls: no prior positive diagnosis of microscopic, collagenous or lymphocytic colitis.
Exclusion criteria
- Age below 18 years at the time of diagnosis
- Use of anticoagulants or immunosuppressive drugs
- Severe co-morbidities (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorders and any co-morbidity hindering an endoscopic procedure)
- A previous history of any type of chronic colitis (other than MC), irritable bowel syndrome, colon carcinoma or (partial) colectomy
- A recent (last year) diagnosis of infectious diarrhea or radiation proctitis.
- Use of medication known for influencing intestinal permeability
- Excessive alcohol usage (>20 standard units per week)
- Not capable of signing an informed consent
- Defaecation diary is not matching the predefined stool frequency for the designated patient group (active, remission, control)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48505.068.14 |