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

Ex Vivo Experiments to Evaluate the Role of Medication on the Colon Permeability in Microscopic Colitis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02303132

Enrollment

Registered

2014-11-27

Start date

2015-11-30

Completion date

2016-07-31

Last updated

2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microscopic Colitis

Brief summary

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

Interventions

OTHERUssing experiment

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in Transepithelial electircal resistance	2 hours

Secondary

Measure	Time frame
Change in permeation of a fluorescent marker	2 hours

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026