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Completed

NCT Number: NCT02303132

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

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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Key information

Conditions

Microscopic Colitis Colitis Colitis, Microscopic Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ussing experiment

Other

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

Primary outcomes

  1. Change in Transepithelial electircal resistance

    Time frame: 2 hours

Secondary outcomes

  1. Change in permeation of a fluorescent marker

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2014
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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