Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-07-31

Brief Summary

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Medication use, especially NSAIDs and PPIs, 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 fresh colon tissue samples. The primary objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial permeability of colon biopsy specimens of MC and non-MC patients, using the Ussing chamber system

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Detailed Description

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Conditions

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Microscopic Colitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Active MC

Patients with active MC will be included

Group Type OTHER

Ussing experiment

Intervention Type OTHER

fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.

MC in remission

Patients with MC in remission will be included

Group Type OTHER

Ussing experiment

Intervention Type OTHER

fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.

Controls

Patients without MC will be included

Group Type OTHER

Ussing experiment

Intervention Type OTHER

fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.

Interventions

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Ussing experiment

fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The indication for colonoscopy is a relapse of MC (active) / MC in remission (remission) / no MC (control)
* Patient is not treated with NSAIDs / PPI / SSRI in week before inclusion

Exclusion Criteria

* Age below 18 years at the time of diagnosis
* Use of anticoagulants or immunosuppressive drugs
* Severe co-morbidities hindering an endoscopic procedure
* A previous history of any type of chronic colitis, IBS, IBD, colon carcinoma or (partial) colectomy
* A recent (last year) diagnosis of infectious diarrhea or radiation proctitis.
* Use of medication known to influence intestinal permeability
* Excessive alcohol usage (\>20 standard units per week)
* Not capable of signing an informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes